Recall Z-2226-2021— Biomerieux Inc

Name: FDA recall Z-2226-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-24

Class II · Terminated

Class II FDA medical device recall by Biomerieux Inc, initiated 2021-06-24, terminated 2025-02-10. It names one FDA 510(k) clearance: K191953. Product: ETEST IMIPENEM RELEBACTAM. in vitro diagnostic. Reason: Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains..

Recalling firm: Biomerieux Inc
Classification: Class II
Status: Terminated
Initiated: 2021-06-24
Terminated: 2025-02-10
Firm location: Hazelwood, MO, United States

510(k) clearances named in this recall

1 on FDA's record

K191953 — ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)Biomerieux S.A.·cleared 2019-08-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ETEST IMIPENEM RELEBACTAM. in vitro diagnostic

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.