Remel RapID Yeast Plus System Recalled for Mislabeled Reagents
Remel Inc is recalling 150 kits of the RapID Yeast Plus System because the labels for Reagent A and Reagent B were reversed.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling error (reversed labels) which is a minor labeling issue without reported injuries, fitting the Moderate criteria.
Plain-English summary
Remel Inc is recalling 150 kits of the RapID Yeast Plus System, Reference R8311007. This in vitro diagnostic (IVD) product is used for the biochemical identification of medically important yeast and yeast-like organisms. Each kit contains a 15-ml bottle of RapID Yeast Plus Reagent A and a 10-ml bottle of RapID Yeast Plus Reagent B.
The recall was initiated because the labels on the two reagent bottles were reversed. This mislabeling could lead to incorrect identification of yeast species if the reagents are used as labeled.
The affected product is Lot 302532, with an expiration date of February 6, 2014. The kits were distributed worldwide, including nationwide in the United States (specifically in AL, AZ, CA, CT, FL, ID, IN, KY, MA, MI, MS, NJ, OH, PA, TX, and WI) and in Canada, the UK, and Japan. Users should stop using the product and contact Remel Inc for instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- Remel Inc
- Hazard
- Affected units
- 150
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 302532
- Exp 6 Feb 2014
Distribution
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