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FDA (Device enforcement)Recalled 2021-06-18closedclass ii

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

Is my product affected?

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

  • UPC 05032384006533

Check against the official notice below — it lists the full affected range.

What happened

Remel Inc is recalling ThermoScientific Oxoid Antimicrobial Susceptibility Discs (a prescription-only product made in the United Kingdom) due to the product being out of specification. The affected product is model CT0223B across 15 lot numbers: 2341375, 2343397, 2394162, 2403210, 2438023, 2463120, 2408058, 2438086, 2457651, 2832507, 2840771, 2935065, 2958576, 2968037, and 2978564. A total of 327 units were distributed worldwide, including throughout the United States and territories such as Puerto Rico and Bermuda.

The recall notice does not specify a recommended remedy or action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Out of Specification

Details from the source

Reason for recall: Out of Specification Distribution: 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. Quantity: 327 units Lot/code info: Model: CT0223B Lots#'s: 2341375, 2343397, 2394162, 2403210, 2438023, 2463120, 2408058, 2438086, 2457651, 2832507, 2840771, 2935065, 2958576, 2968037 and 2978564 UDI-DI: 05032384006533

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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