Biomerieux Inc ETEST IMIPENEM RELEBACTAM. in vitro diagnostic Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Brand
Biomerieux Inc
Lot Codes / Batch Numbers
Ref 420927 (US Product) Lot numbers 1007888860, 1008598340, 1008701580, 1007607290, 1007888870, 1008390030, 1008598350 and 1008701590 and Ref 420925 (not distributed in US):Lot Codes: 1007888860, 100859840 and 1008701580
Products Sold
Ref 420927 (US Product) Lot numbers 1007888860, 1008598340, 1008701580, 1007607290, 1007888870, 1008390030, 1008598350 and 1008701590 and Ref 420925 (not distributed in US):Lot Codes: 1007888860, 100859840 and 1008701580
Biomerieux Inc is recalling ETEST IMIPENEM RELEBACTAM. in vitro diagnostic due to Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
Recommended Action
Per FDA guidance
The recall notification was issued to the impacted subsidiaries and distributors on 24JUN2021. The notification includes a Customer Letter to be translated into local language and sent to each impacted customer. The customer letter will inform the customers about the MIC overestimation and false resistant results issue and will be instructed to: - Perform a retest using an alternative method on P. aeruginosa strains for which they obtained resistant or intermediate results with ETEST IMIPENEM RELEBACTAM ref. 420925 and 420927 - Among tests previously performed, identify any possible false resistant/intermediate results that may have occurred, to analyze the related risks and to determine appropriate actions if relevant.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026