Recall Z-2142-2021— Remel Inc

Name: FDA recall Z-2142-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-18

Class II · Terminated

Class II FDA medical device recall by Remel Inc, initiated 2021-06-18, terminated 2023-08-04. It names one FDA 510(k) clearance: K982524. Product: ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom. Reason: Out of Specification.

Recalling firm: Remel Inc
Classification: Class II
Status: Terminated
Initiated: 2021-06-18
Terminated: 2023-08-04
Firm location: Lenexa, KS, United States

510(k) clearances named in this recall

1 on FDA's record

K982524 — AMOXICILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISCOxoid , Ltd.·cleared 1998-09-09

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

ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom

Reason for recall

Out of Specification

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