medical Class II Updated 2021-08-18

Biomerieux Inc recalls ETEST IMIPENEM RELEBACTAM. in vitro diagnostic

Recalled Product

ETEST IMIPENEM RELEBACTAM. in vitro diagnostic


Hazard / Issue

Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
View official government recall

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