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Recall Observatory FDA recall evidence

Device product

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

Z-2142-2021

June 18, 2021

Class II

Product summary

Firm
Remel Inc
Event
Event 88205
Status
Terminated
Classification
Class II
Quantity
327 units
Official record key
device-enforcement:Z-2142-2021

Official wording

Reason: Out of Specification

Code information: Model: CT0223B Lots#'s: 2341375, 2343397, 2394162, 2403210, 2438023, 2463120, 2408058, 2438086, 2457651, 2832507, 2840771, 2935065, 2958576, 2968037 and 2978564 UDI-DI: 05032384006533

Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, District of Columbia, Hawaii and Puerto Rico. The countries of BERMUDA.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of Specification