Recall Z-2095-2017— BioMerieux SA

Name: FDA recall Z-2095-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-25

Class II · Terminated

Class II FDA medical device recall by BioMerieux SA, initiated 2017-04-25, terminated 2022-02-24. It names one FDA 510(k) clearance: K020748. Product: ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria (Only 531640 was distributed in the United States). Reason: False susceptible results.

Recalling firm: BioMerieux SA
Classification: Class II
Status: Terminated
Initiated: 2017-04-25
Terminated: 2022-02-24
Firm location: Marcy L'Etoile, France

510(k) clearances named in this recall

1 on FDA's record

K020748 — ETEST ERTAPENEMAb Biodisk·cleared 2002-04-29

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 ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria (Only 531640 was distributed in the United States)

Reason for recall

False susceptible results

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