Reported Mar 29, 2017 · Terminated
ETEST¿ Ceftriaxone TXL32 SPB, Product Name: ETEST¿ Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for…
BioMerieux SA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BioMerieux SA · Chemin De L'Orme · Marcy L'Etoile · N/A
Is this the product you have?
- ETEST¿ Ceftriaxone TXL32 SPB
- Product NameETEST¿ 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 Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 Reference no. 412302 2 Lot #1002939460, 1003361690, 1003848910, 1004041770, 1004394530, 1004731200 & 1004876830 and 3 Reference no. 412303 4 Lot # 1002939450, 1003089900, 1003813690, 1003851120, 1003953500, 1004152070, 1004315690, 1004394520, 1004525320, 1002939450, 1003089900, 1004755940, 1004828440, 1004876840 & 1005118100. - Amount recalled
- unknown
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
- Nationwide
- GA
Why it was recalled
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
This product could cause temporary or reversible health problems — stop using it.
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