Recalls / —
—#119041
Product
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 product code
- JXB — Kit, Identification, Yeast
- Device class
- Class 1
- Medical specialty
- Microbiology
- 510(k) numbers
- K943621
- Affected lot / code info
- Lot 302532, Exp 6 Feb 2014
Why it was recalled
The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The labels were reversed.
Root cause (FDA determination)
Labeling mix-ups
Action the firm took
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).
Recalling firm
- Firm
- Remel Inc
- Address
- 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519
Distribution
- 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.
Timeline
- Recall initiated
- 2013-04-04
- Posted by FDA
- 2013-12-17
- Terminated
- 2014-03-12
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #119041. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.