Recall Z-2126-2017— BioMerieux SA

Name: FDA recall Z-2126-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-01

Class II · Terminated

Class II FDA medical device recall by BioMerieux SA, initiated 2017-01-01, terminated 2022-02-24. It names one FDA 510(k) clearance: K945433. Product: Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic ba. Reason: Potential performance issue on strain categorization..

Recalling firm: BioMerieux SA
Classification: Class II
Status: Terminated
Initiated: 2017-01-01
Terminated: 2022-02-24
Firm location: Marcy L'Etoile, France

510(k) clearances named in this recall

1 on FDA's record

K945433 — ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUSAb Biodisk·cleared 1995-03-17

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

Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic ba

Reason for recall

Potential performance issue on strain categorization.

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