Remel Inc: Medical Device Recall in 2013 - (Recall #: Z-0530-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 4, 2013

Date Posted: December 25, 2013

Recall Number: Z-0530-2014

Event ID: 65477

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.

Status: Terminated

Product Quantity: 150 kits

Code Information:

Lot 302532, Exp 6 Feb 2014

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.

Voluntary or Mandated:

Voluntary: Firm initiated