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Biomerieux Inc

514 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 REF 420144), 20 cards/kit. Produ recall (Z-1647-2016)Biomerieux Inc2016-05-11
VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioM recall (Z-1596-2016)Biomerieux Inc2016-05-03
Granada Biphasic Broth The product is a selective medium for the screening and identificat recall (Z-0556-2016)Biomerieux Inc2015-12-29
MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer application software. recall (Z-1621-2015)bioMerieux, Inc.2015-05-15
Vitek 2 AST-YS06 REF 412 610, Fungal Susceptibility Card, 20 cards per carton, IVD. Intend recall (Z-1601-2015)Biomerieux Inc2015-05-12
Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton, IVD. Intend recall (Z-1602-2015)Biomerieux Inc2015-05-12
Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton, IVD. Intende recall (Z-1603-2015)Biomerieux Inc2015-05-12
Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IV recall (Z-1401-2015)Biomerieux Inc2015-04-08
Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IV recall (Z-1402-2015)Biomerieux Inc2015-04-08
Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, IVD. recall (Z-1403-2015)Biomerieux Inc2015-04-08
bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), ( recall (Z-1177-2014)Biomerieux Inc2014-03-12
chromID Salmonella Agar, Reference No. 43621. A selective isolation and differentiation me recall (Z-0087-2014)bioMerieux, Inc.2013-10-28
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated recall (Z-1907-2013)Biomerieux Inc2013-08-06
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated recall (Z-1908-2013)Biomerieux Inc2013-08-06
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated recall (Z-1909-2013)Biomerieux Inc2013-08-06
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated recall (Z-1910-2013)Biomerieux Inc2013-08-06
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated recall (Z-1911-2013)Biomerieux Inc2013-08-06
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated recall (Z-1912-2013)Biomerieux Inc2013-08-06
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated recall (Z-1913-2013)Biomerieux Inc2013-08-06
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated recall (Z-1914-2013)Biomerieux Inc2013-08-06
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated recall (Z-1915-2013)Biomerieux Inc2013-08-06
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated recall (Z-1916-2013)Biomerieux Inc2013-08-06
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated recall (Z-1917-2013)Biomerieux Inc2013-08-06
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated recall (Z-1918-2013)Biomerieux Inc2013-08-06
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated recall (Z-1919-2013)Biomerieux Inc2013-08-06
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated recall (Z-1920-2013)Biomerieux Inc2013-08-06
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated recall (Z-1921-2013)Biomerieux Inc2013-08-06
bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with V recall (Z-1013-2013)Biomerieux Inc2013-03-27
VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) recall (Z-0989-2013)Biomerieux Inc2013-03-25
VITEK 2 XL computer system when equipped with the following Hewlett-Packard PC models: (1) recall (Z-0990-2013)Biomerieux Inc2013-03-25
VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models recall (Z-0991-2013)Biomerieux Inc2013-03-25
BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be rec recall (Z-0738-2013)bioMerieux, Inc.2013-01-25
0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The concentrated s recall (Z-0430-2013)Biomerieux Inc2012-11-22
bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrument The produ recall (Z-0299-2013)Biomerieux Inc2012-11-16
bioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical instrument The produc recall (Z-0300-2013)Biomerieux Inc2012-11-16
bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument The product is mo recall (Z-0301-2013)Biomerieux Inc2012-11-16
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument software, Engli recall (Z-0302-2013)Biomerieux Inc2012-11-16
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML 02, Clinical instrument software, Engl recall (Z-0303-2013)Biomerieux Inc2012-11-16
bioMerieux Kit, Instrument & Update, 3D B.40 BTA3D-ZH01, Clinical instrument software, Chi recall (Z-0304-2013)Biomerieux Inc2012-11-16
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument software, Danis recall (Z-0305-2013)Biomerieux Inc2012-11-16
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML04, Clinical instrument software, Czech recall (Z-0306-2013)Biomerieux Inc2012-11-16
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML05, Clinical instrument software, Lithu recall (Z-0307-2013)Biomerieux Inc2012-11-16
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML06, Clinical instrument software, Japan recall (Z-0308-2013)Biomerieux Inc2012-11-16
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument software, Engli recall (Z-0309-2013)Biomerieux Inc2012-11-16
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML02, Clinical instrument software, Germa recall (Z-0310-2013)Biomerieux Inc2012-11-16
bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and moun recall (Z-0311-2013)Biomerieux Inc2012-11-16
bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update and recall (Z-0312-2013)Biomerieux Inc2012-11-16
bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, USB update an recall (Z-0313-2013)Biomerieux Inc2012-11-16
bioMerieux Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrument software, D recall (Z-0314-2013)Biomerieux Inc2012-11-16
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument software, Czech recall (Z-0315-2013)Biomerieux Inc2012-11-16
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML05, Clinical instrument software, Lithu recall (Z-0316-2013)Biomerieux Inc2012-11-16
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument software, Japan recall (Z-0317-2013)Biomerieux Inc2012-11-16
bioMerieux BacT/ALERT Control Module, catalog number 210148, Industrial instrument The pro recall (Z-0318-2013)Biomerieux Inc2012-11-16
bioMerieux BacT/ALERT Combo Module, catalog number 200291, Industrial instrument The produ recall (Z-0319-2013)Biomerieux Inc2012-11-16
bioMerieux BacT/ALERT Combo Module, catalog number 247014, Industrial instrument The produ recall (Z-0320-2013)Biomerieux Inc2012-11-16
bioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument software update recall (Z-0321-2013)Biomerieux Inc2012-11-16
bioMerieux Kit, Instrument & Update, 3D IND USB-ML 02, Industry instrument software update recall (Z-0322-2013)Biomerieux Inc2012-11-16
bioMerieux Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument software update, E recall (Z-0323-2013)Biomerieux Inc2012-11-16
bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrument software u recall (Z-0324-2013)Biomerieux Inc2012-11-16
bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML02, Industry instrument software u recall (Z-0325-2013)Biomerieux Inc2012-11-16
bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument software upd recall (Z-0326-2013)Biomerieux Inc2012-11-16
bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument software upd recall (Z-0327-2013)Biomerieux Inc2012-11-16
bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument software upd recall (Z-0328-2013)Biomerieux Inc2012-11-16
bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02, Industry instrument software upd recall (Z-0329-2013)Biomerieux Inc2012-11-16
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intend recall (Z-0023-2013)Biomerieux Inc2012-10-09
BacT/ALERT Blood Collection Adapter The BacT/ALERT Adapter Cap is intended for use as an a recall (Z-1336-2012)bioMerieux, Inc.2012-03-30
SLIDEX Staph kit (250 Tests). The SLIDEX Staph-Kit is a rapid latex and red blood cell agg recall (Z-1045-2012)bioMerieux, Inc.2012-02-16
VIDAS Chlamydia test kits VIDAS Chlamydia is an automated qualitative test for use on the recall (Z-3129-2011)bioMerieux, Inc.2011-09-02
VITEK 2 System, VITEK 2 60 110V (Catalog #27225) and VITEK 2 60 220V (Catalog #27226). VIT recall (Z-2767-2011)Biomerieux Inc2011-07-09
VITEK 2 System, VITEK 2 XL 110V (Catalog #27227) and VITEK 2 XL 220V (Catalog #27228). VIT recall (Z-2768-2011)Biomerieux Inc2011-07-09
NucliSens EasyQ Enterovirus serotype 68 v1.1: Catalog number: 200300 In Vitro Diagnostic T recall (Z-2740-2011)bioMerieux, Inc.2011-07-06
BacT/ALERT - FA Reagent Bottle The BacT/ALERT Microbial Detection System is used to determ recall (Z-2244-2011)bioMerieux, Inc.2011-05-24
VITEK 2 Gram Negative Susceptibility Card, AST-N183, REF 411 021, For In Vitro Diagnostic recall (Z-2049-2011)Biomerieux Inc2011-04-27
VITEK 2 Gram Negative Susceptibility Card, AST-N184, REF 411 154, For In Vitro Diagnostic recall (Z-2050-2011)Biomerieux Inc2011-04-27
VITEK 2 Gram Negative Susceptibility Card, AST-GN22, REF 22 227, For In Vitro Diagnostic U recall (Z-0172-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN23, REF 22 228, For In Vitro Diagnostic U recall (Z-0173-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN24, REF 22 229, For In Vitro Diagnostic U recall (Z-0174-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN25, REF 22 230, For In Vitro Diagnostic U recall (Z-0175-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN26, REF 22 244, For In Vitro Diagnostic U recall (Z-0176-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN27, REF 22 245, For In Vitro Diagnostic U recall (Z-0177-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN28, REF 22 254, For In Vitro Diagnostic U recall (Z-0178-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN29, REF 22 266, For In Vitro Diagnostic U recall (Z-0179-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN30, REF 22 267, For In Vitro Diagnostic U recall (Z-0180-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN31, REF 22 268, For In Vitro Diagnostic U recall (Z-0181-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN32, REF 22 269, For In Vitro Diagnostic U recall (Z-0182-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN33, REF 22 270, For In Vitro Diagnostic U recall (Z-0183-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN34, REF 22 271, For In Vitro Diagnostic U recall (Z-0184-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN35, REF 22 286, For In Vitro Diagnostic U recall (Z-0185-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN36, REF 22 300, For In Vitro Diagnostic U recall (Z-0186-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN37, REF 22 312, For In Vitro Diagnostic U recall (Z-0187-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN39, REF 22 337, For In Vitro Diagnostic U recall (Z-0188-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN41, REF 410 757, For In Vitro Diagnostic recall (Z-0189-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-GN42, REF 410 758, For In Vitro Diagnostic recall (Z-0190-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N080, REF 22 214, For In Vitro Diagnostic U recall (Z-0191-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N081, REF 22 215, For In Vitro Diagnostic U recall (Z-0192-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N082, REF 22 217, For In Vitro Diagnostic U recall (Z-0193-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N084, REF 22 224, For In Vitro Diagnostic U recall (Z-0194-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N085, REF 22 225, For In Vitro Diagnostic U recall (Z-0195-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N086, REF 22 234, For In Vitro Diagnostic U recall (Z-0196-2011)Biomerieux Inc2010-11-11
VITEK 2 Gram Negative Susceptibility Card, AST-N087, REF 22 235, For In Vitro Diagnostic U recall (Z-0197-2011)Biomerieux Inc2010-11-11
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