Device product
ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom
Z-2142-2021
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
Out of Specification