Recall Z-1529-2017 ยท JWY Manual Antimicrobial Susceptibility Test Systems
BioMerieux SA
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 Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus s
| Date | Mar 21, 2017 (initiated Dec 15, 2016) |
| Status | Terminated |
| Reason | Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing. |
| Root cause | Storage |
| Action | biomerieux sent an Urgent Field Safety Notice dated December 15, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to identify the affected lots and immediately order the replacement products. Laboratories should continue to follow their current QC procedures. When replacement product is received, consignees should discontinue using any discard affected product. Consignees should distribute this information to all appropriate personnel in their laboratory, retain a copy in their files, |
| Quantity | unknown |
| Distribution | Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portuga |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960989 | ETEST SUBMISSION FOR IMIPENEM Ab Biodisk, May 20, 1996 |