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Remel, Inc

84 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460 recall (Z-2623-2026)Remel, Inc2026-06-30
Yeastone Broth, 11ML, 10/BOX YY3462 recall (Z-1806-2026)Remel, Inc2026-04-10
Campy CVA Medium 100/PK, R01272 recall (Z-1474-2026)Remel, Inc2026-02-26
1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450 recall (Z-0585-2026)Remel, Inc2025-11-21
Blood Agar,5% Sheep Blood 100/PK, Product Number R01202 recall (Z-2223-2025)Remel, Inc2025-07-31
Strep Selective II Agar, Product Number R01859 recall (Z-2224-2025)Remel, Inc2025-07-31
Blood/EMB, Levine 100/PK, Product Number R02041 recall (Z-2225-2025)Remel, Inc2025-07-31
Blood/MacConkey Biplate 100/PK, Product Number R02049 recall (Z-2226-2025)Remel, Inc2025-07-31
Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed recall (Z-1947-2025)Remel, Inc2025-06-11
Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold a recall (Z-1395-2025)Remel, Inc2025-03-19
remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use recall (Z-1200-2025)Remel, Inc2025-02-20
remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use recall (Z-1201-2025)Remel, Inc2025-02-20
remel BactiDrop Acridine Orange, REF 21502, 50 per package. recall (Z-0266-2025)Remel, Inc2024-10-30
remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci fo recall (Z-2531-2023)Remel, Inc2023-09-08
Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Tes recall (Z-2038-2023)Remel, Inc2023-06-29
Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST recall (Z-0327-2023)Remel Inc2022-12-08
Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST recall (Z-0328-2023)Remel Inc2022-12-08
Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST recall (Z-0329-2023)Remel Inc2022-12-08
Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST recall (Z-0330-2023)Remel Inc2022-12-08
Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST recall (Z-0331-2023)Remel Inc2022-12-08
Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST recall (Z-0332-2023)Remel Inc2022-12-08
Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST recall (Z-0333-2023)Remel Inc2022-12-08
Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST recall (Z-0334-2023)Remel Inc2022-12-08
Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST recall (Z-0335-2023)Remel Inc2022-12-08
Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 6 recall (Z-1888-2017)Remel Inc2017-04-27
PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test recall (Z-2350-2015)Remel Inc2015-08-07
PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a recall (Z-2351-2015)Remel Inc2015-08-07
VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK System recall (Z-1841-2015)Remel Inc2015-06-25
VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System recall (Z-1842-2015)Remel Inc2015-06-25
Remel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per pack, 10/10-p recall (Z-1748-2015)Remel Inc2015-06-10
Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The recall (Z-1232-2015)Remel Inc2015-03-02
Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The recall (Z-0465-2015)Remel Inc2014-12-16
Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a vari recall (Z-0466-2015)Remel Inc2014-12-16
Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supp recall (Z-0578-2015)Remel Inc2014-12-12
Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A recall (Z-0449-2015)Remel Inc2014-11-25
Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growt recall (Z-0200-2015)Remel Inc2014-11-10
Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bott recall (Z-2057-2014)Remel Inc2014-07-15
Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a vari recall (Z-1473-2014)Remel Inc2014-04-18
Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box. The box contain recall (Z-1474-2014)Remel Inc2014-04-18
Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The fir recall (Z-1246-2014)Remel Inc2014-03-20
Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/ recall (Z-1112-2014)Remel Inc2014-02-26
Oxoid Antimicrobial Susceptibility Test Discs, Cefpodoxime 10 mcg., CT1612B, packaged in c recall (Z-0792-2014)Remel Inc2014-01-21
Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg., CT0434B, packaged in c recall (Z-0793-2014)Remel Inc2014-01-21
Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, packaged in ca recall (Z-0794-2014)Remel Inc2014-01-21
Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B, packaged in car recall (Z-0795-2014)Remel Inc2014-01-21
Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Pa recall (Z-0734-2014)Remel Inc2014-01-14
Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The k recall (Z-0537-2014)Remel Inc2013-12-18
Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 te recall (Z-0538-2014)Remel Inc2013-12-18
Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs p recall (Z-0528-2014)Remel Inc2013-12-17
remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of recall (Z-0530-2014)Remel Inc2013-12-17
Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packag recall (Z-2081-2013)Remel Inc2013-08-26
Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package recall (Z-1962-2013)Remel Inc2013-08-13
Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests recall (Z-0806-2013)Remel Inc2013-02-12
Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests recall (Z-0807-2013)Remel Inc2013-02-12
Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 dis recall (Z-0808-2013)Remel Inc2013-02-12
The product is a lyophilized growth supplement for use with dehydrated culture media to pr recall (Z-0801-2013)Remel Inc2013-02-11
Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Lt recall (Z-0790-2013)Remel Inc2013-02-06
remel Haemophilus Test Medium (Agar), 100mm plates, 10/pk, Ref. #R01503. The firm name on recall (Z-2928-2011)Remel Inc2011-08-03
remel Haemophilus Test Medium (Agar), 150mm plates, 10/pk, Ref. #R04033. The firm name on recall (Z-2929-2011)Remel Inc2011-08-03
Remel Spectra MRSA, Ref R01821, 10 plates per package, and Ref R01822, 100 plates per pack recall (Z-2677-2011)Remel Inc2011-06-28
remel A.C.T. II Sterile Pack Tube, Collection and Transport System, Ref 12402, 10/pk, each recall (Z-1139-2010)Remel, Inc2010-03-15
Oxoid CM0225 Brain Heart Infusion IVD. The firm name on the label is Oxoid Ltd., Basingsto recall (Z-0979-2010)Remel, Inc2010-03-09
ERIC (Electronic RapID Compendium) Version 1.0.77, Catalog Number R8323600, used in conjun recall (Z-0870-2010)Remel, Inc2010-02-26
Oxoid dry Spot Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Oxoid Ltd., Wade road, Ba recall (Z-0817-2010)Remel, Inc2010-02-23
Staphytect Plus, packaged in 100- and 500-test boxes, Catalog #DR0850M (100 tests) and #DR recall (Z-0818-2010)Remel, Inc2010-02-23
remel Mueller Hinton Agar w/4% NaCl w/6 mcg/ml Oxacillin, Ref R01626, 10/box. The firm nam recall (Z-0644-2010)Remel, Inc2010-01-15
Remel BactiSwab NPG Collection and Transport System, Sterile, 100 swab units/box, Catalog recall (Z-1812-2009)Remel, Inc2009-08-18
Remel Middlebrook 7H10 Agar, Ref R01600, packaged 10 units/package. The firm name on the l recall (Z-1733-2009)Remel, Inc2009-08-14
Remel Staphaurex Plus Kit, Catalog No. R30950102 (150 tests) and Catalog No. R30950201 (45 recall (Z-1400-2009)Remel, Inc2009-05-19
Dryspot (R) Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Latex slide agglutination te recall (Z-1008-2009)Remel, Inc2009-03-20
Xpect Giardia/Cryptosporidium Kit, Ref 24050520, 20 tests per kit, For In Vitro Diagnostic recall (Z-2432-2008)Remel, Inc2008-09-19
Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Pa recall (Z-1624-2008)Remel Inc2008-05-14
Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Pa recall (Z-1625-2008)Remel Inc2008-05-14
Remel MacConkey Agar w/Sorbitol, growth medium, Catalog R01556, packaged 10/box. The firm recall (Z-0621-2007)Remel, Inc.2007-03-14
Oxoid Infectious Mononucleosis Test, Catalog #DR0680M. The firm name on the label is Oxoid recall (Z-0786-06)Remel, Inc.2006-04-22
Remel Chocolate Agar, catalog #01301, containing 15 plates/pkg, for in-vitro diagnostic us recall (Z-0024-05)Remel, Inc.2004-10-20
ProSpecT Campylobacter Microplate Assay. Catalog #2476096. recall (Z-1372-04)Remel, Inc.2004-08-17
ProSpecT Shiga Toxin E. coli (STEC) Micorplate Assay. Catalog #: 2474048 (48 well plate) a recall (Z-1373-04)Remel, Inc.2004-08-17
ProSpecT Giardia/Cryptosporidium Micorplate Assay. Catalog #: 2458496. recall (Z-1374-04)Remel, Inc.2004-08-17
ProSpecT Giardia/Cryptosporidium Microplate Assay. Catalog #: 2458496. recall (Z-1375-04)Remel, Inc.2004-08-17
ProSpecT Cryptosporidium Microplate Assay. Catalog #2454096. recall (Z-1376-04)Remel, Inc.2004-08-17
Remel QC-Slide Gram Stain Control, Catalog #40142, packaged 45/box. The responsible firm o recall (Z-0273-04)Remel, Inc.2003-12-25
Remel Thayer Martin Agar (Improved), packaged in 10-packs (Cat. #01884), 15-packs (Cat. #0 recall (Z-0069-04)Remel, Inc2003-10-24
REMEL CXM 30 Cefuroxime 30 mcg, Antimicrobial Susceptibility Test Disk, 50 disks to a cart recall (Z-0613-03)Remel, Inc.2003-03-06

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Every clearance here is in the API, with alerts when new ones post.