Recall Z-0530-2014 ยท JXB Kit, Identification, Yeast
Remel Inc
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.
| Date | Dec 17, 2013 (initiated Apr 4, 2013) |
| Status | Terminated |
| Reason | The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The labels were reversed. |
| Root cause | Labeling mix-ups |
| 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). |
| Quantity | 150 kits |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943621 | RAPID YEAST PLUS SYSTEM Innovative Diagnostic Systems, Inc., Jan 27, 1995 |