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BioMerieux SA

31 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For recall (Z-2331-2018)BioMerieux SA2018-06-29
ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determini recall (Z-0264-2018)BioMerieux SA2017-12-19
ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for determini recall (Z-0265-2018)BioMerieux SA2017-12-19
ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative tec recall (Z-2095-2017)BioMerieux SA2017-05-03
Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST is a recall (Z-2126-2017)BioMerieux SA2017-05-03
ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.016-256. ETES recall (Z-1521-2017)BioMerieux SA2017-03-21
ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.016-256. ETES recall (Z-1522-2017)BioMerieux SA2017-03-21
ETEST Ceftriaxone TXL32 SPB, Product Name: ETEST Ceftriaxone TX 0.002-32(low). ETEST is a recall (Z-1523-2017)BioMerieux SA2017-03-21
Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.002-32. ETEST i recall (Z-1524-2017)BioMerieux SA2017-03-21
ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.016-256. ETEST recall (Z-1525-2017)BioMerieux SA2017-03-21
ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32. ETEST is recall (Z-1526-2017)BioMerieux SA2017-03-21
ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenicillin PG 0.01 recall (Z-1527-2017)BioMerieux SA2017-03-21
ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM 0.064-1024. E recall (Z-1528-2017)BioMerieux SA2017-03-21
ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32. ETEST is a q recall (Z-1529-2017)BioMerieux SA2017-03-21
ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.016-256(low). E recall (Z-1530-2017)BioMerieux SA2017-03-21
ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.016-256(low). E recall (Z-1531-2017)BioMerieux SA2017-03-21
ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low). recall (Z-1532-2017)BioMerieux SA2017-03-21
VIDAS Estradiol II, Ref 30431-01, 60 tests The VIDAS Estradiol II (E2 II) assay is intende recall (Z-1801-2017)BioMerieux SA2017-03-20
NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the re recall (Z-1713-2017)BioMerieux SA2017-03-19
VIDAS 3 software v. 1.1.4 recall (Z-1200-2017)BioMerieux SA2017-02-14
MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS easyMAG system is recall (Z-0976-2017)BioMerieux SA2017-01-13
NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliS recall (Z-0977-2017)BioMerieux SA2017-01-13
NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents an recall (Z-2342-2016)BioMerieux SA2016-08-09
API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for reveal recall (Z-0756-2016)BioMerieux SA2016-02-04
Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic. recall (Z-1947-2015)BioMerieux SA2015-07-01
VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the V recall (Z-2232-2014)BioMerieux SA2014-08-14
VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prost recall (Z-2152-2014)BioMerieux SA2014-08-06
ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to reveal the resu recall (Z-1475-2014)BioMerieux SA2014-04-18
FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results of recall (Z-1476-2014)BioMerieux SA2014-04-18
API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and A recall (Z-1477-2014)BioMerieux SA2014-04-18
API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF 10400) recall (Z-1478-2014)BioMerieux SA2014-04-18

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