FDA (Devices) recall action 76201

BioMerieux SA recalled 12 products on 2017-03-29

The FDA (Devices) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.

Products: 12
Announced: 2017-03-29
Critical: 0
Units: —

Why these products were recalled

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

The agency’s own wording, quoted from the enforcement report.

1–12 of 12

ModerateFDA (Devices)··2017-03-29
BioMerieux Recalls ETEST Imipenem IP32 Foam Packaging Due to Stability Issues
BioMerieux SA is recalling ETEST Imipenem IP32 Foam packaging because the current shelf-life claims are not supported by internal testing.
Product
ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Entero
Category
Distribution
0 states
ModerateFDA (Devices)··2017-03-29
BioMerieux Recalls ETEST Fosfomycin Strips Due to Unsupported Shelf-Life Claims
BioMerieux SA is recalling ETEST Fosfomycin FM1024 strips because internal testing does not support the current shelf-life claims.
Product
ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM 0.064-1024. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus
Category
Distribution
0 states
ModerateFDA (Devices)··2017-03-29
BioMerieux Recalls Etest Benzyl Penicillin Strips Due to Stability Issues
BioMerieux SA is recalling Etest Benzyl Penicillin PG256 FOAM packaging because shelf-life claims are not supported by internal testing.
Product
ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenicillin PG 0.016-256 (high). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas,
Category
Distribution
0 states
ModerateFDA (Devices)··2017-03-29
BioMerieux Recalls ETEST Cephalothin CE 256 Foam Packaging Due to Stability Issues
BioMerieux SA is recalling ETEST Cephalothin CE 256 Foam packaging because current shelf-life claims are not supported by internal testing.
Product
ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.016-256. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus an
Category
Distribution
0 states
ModerateFDA (Devices)··2017-03-29
BioMerieux Recalls ETEST Ceftriaxone Strips Due to Stability Issues
BioMerieux SA is recalling ETEST Ceftriaxone antimicrobial susceptibility testing strips because their shelf-life claims are not supported by internal testing.
Product
ETEST¿ Ceftriaxone TXL32 SPB, Product Name: ETEST¿ Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Ent
Category
Distribution
0 states
ModerateFDA (Devices)··2017-03-29
BioMerieux Recalls ETEST Doripenem Strips Due to Stability Issues
BioMerieux SA is recalling ETEST Doripenem DOR32 FOAM packaging strips because internal testing does not support the current shelf-life claims.
Product
ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and E
Category
Distribution
0 states
ModerateFDA (Devices)··2017-03-29
BioMerieux Recalls ETEST Ceftriaxone Strips Due to Stability Issues
BioMerieux SA is recalling ETEST Ceftriaxone strips because their shelf-life claims are not supported by internal testing. The products were distributed worldwide.
Product
ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcu
Category
Distribution
0 states
ModerateFDA (Devices)··2017-03-29
BioMerieux Recalls ETEST Vancomycin Strips Due to Stability Issues
BioMerieux SA is recalling ETEST Vancomycin antimicrobial susceptibility testing strips because their shelf-life claims are not supported by internal testing.
Product
ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.016-256. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and
Category
Distribution
0 states
ModerateFDA (Devices)··2017-03-29
BioMerieux Recalls ETEST Ceftazidime Strips Due to Stability Issues
BioMerieux SA is recalling ETEST Ceftazidime TZ256 strips because their shelf-life claims are not supported by internal testing.
Product
ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.016-256. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus an
Category
Distribution
0 states
ModerateFDA (Devices)··2017-03-29
BioMerieux Recalls ETEST Ciprofloxacin CI 32 Foam Due to Stability Issues
BioMerieux SA is recalling ETEST Ciprofloxacin CI 32 Foam products because their shelf-life claims are not supported by internal testing.
Product
Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.002-32. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and E
Category
Distribution
0 states
ModerateFDA (Devices)··2017-03-29
BioMerieux Recalls ETEST Gentamicin Strips Due to Stability Issues
BioMerieux SA is recalling ETEST Gentamicin antimicrobial susceptibility testing strips because their shelf-life claims are not supported by internal testing.
Product
ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.016-256(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus
Category
Distribution
0 states
ModerateFDA (Devices)··2017-03-29
BioMerieux Recalls ETEST Tobramycin Strips Due to Stability Issues
BioMerieux SA is recalling ETEST Tobramycin antimicrobial susceptibility testing strips because their shelf-life claims are not supported by internal testing.
Product
ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.016-256(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus
Category
Distribution
0 states