remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of RapID Yeast Plus Reagent A and

FDA device recall Z-0530-2014 · posted 2013-12-17 · Terminated

Recall details

Recalling firm

Remel Inc

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.

Action taken

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

Status

Terminated

Product code

JXB

Quantity affected

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.

Date initiated

2013-04-04

Date posted

2013-12-17

Date terminated

2014-03-12

Location

Lenexa, KS

Related 510(k) clearances