BioMerieux SA: 21 recalls on record

Recalls filed with 1 agency: FDA (21).

First recall on record: April 30, 2014. Most recent: August 18, 2021.

Risk classification: Class I: 2 · Class II: 19

Most recent recalls

DateAgencyProduct
August 18, 2021FDAMYLA software. Used to manage microbiology test workflow from the reception of requests …Z-2225-2021
July 4, 2018FDAVIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. …Z-2331-2018
June 20, 2018FDAThe VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Syste…Z-2167-2018
December 27, 2017FDAETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for d…Z-0264-2018
May 24, 2017FDAETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative t…Z-2095-2017
March 29, 2017FDAETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.016-256. ET…Z-1522-2017
March 29, 2017FDACiprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.002-32. ETEST…Z-1524-2017
March 29, 2017FDAETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.016-256(low). …Z-1530-2017
March 29, 2017FDAETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low).…Z-1532-2017
March 29, 2017FDAETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32. ETEST…Z-1526-2017
March 29, 2017FDAETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.016-256. ETE…Z-1525-2017
March 29, 2017FDAETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.016-256. ET…Z-1521-2017
March 1, 2017FDAETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitat…Z-1226-2017
January 25, 2017FDANucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: …Z-0977-2017
January 25, 2017FDAMagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS¿ easyMAG¿ s…Z-0976-2017
August 20, 2014FDAVIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the …Z-2232-2014
August 13, 2014FDAVIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of pros…Z-2152-2014
April 30, 2014FDAZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to reveal the …Z-1475-2014
April 30, 2014FDAAPI Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF 104…Z-1478-2014
April 30, 2014FDAAPI NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) a…Z-1477-2014
April 30, 2014FDAFB Reagent (REF 70562). FB reagent is an additional test used for revealing the result…Z-1476-2014

Questions about this company

How many recalls does BioMerieux SA have?
Recalert has 21 U.S. recalls on record for BioMerieux SA, published between April 30, 2014 and August 18, 2021.
What was the most recent BioMerieux SA recall?
FDA recall Z-2225-2021, published August 18, 2021: MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data.
Which agencies have handled BioMerieux SA recalls?
BioMerieux SA appears as the recalling firm in recalls from: FDA (21).

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