remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of RapID Yeast Plus Reagent A and a 10-ml bottle of RapID Yeast Plus Reagent B. Product Usage: For the biochemical identification of medically important yeast and yeast-like organisms.
FDA Recall Z-0530-2014 · Posted 2013-12-17
Advertisement
Recalling FirmRemel Inc
Recall StatusTerminated
Product CodeJXB
Date Initiated2013-04-04
Date Terminated2014-03-12
Product Quantity150 kits
Reason for Recall
The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The labels were reversed.
Firm Action
Thermo Fisher Scientific sent a Medical Device Recall letter dated April 3, 2013 to affected customers. The letter identified the affected product, problem and actions to be taken. The recalling firm instructed customer to review their inventory for affected lot and discard the product. A Medical Device Recall Return Response was enclosed for the customer to indicate they understood the instructions and to report the amount of product they discarded. For questions call Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).
Root Cause
Labeling mix-ups
Distribution Pattern
Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, CT, FL, ID, IN, KY, MA, MI, MS, NJ, OH, PA, TX, WI and the countries of Canada, UK, and Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement