Reported Aug 18, 2021 · Terminated
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Biomerieux Inc.
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 Inc · 595 Anglum Rd · Hazelwood, MO · 63042-2320
Is this the product you have?
- ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published 420927(US Product) — Lot numbers 1007888860, 1008598340, 1008701580, 1007607290, 1007888870, 1008390030, 1008598350 and 1008701590 and 420925(not distributed in US):Lot Codes: 1007888860, 100859840 and 1008701580 - Amount recalled
- 1,431
Where it was sold
Why it was recalled
Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
This product could cause temporary or reversible health problems — stop using it.
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