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.
What this means for you
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
Related recalls
Same manufacturer · Remel Inc
See all →- HighGC Agar Base Culture Media Reduced Recovery of Neisseria gonorrhoeae
FDA (Devices) · 2026-07-08
- HighYeastone Broth recalled because it may report incorrect susceptibility results
FDA (Devices) · 2026-04-22
- SevereRemel Campy CVA Medium Lot Recalled Over Low Pathogen Recovery
FDA (Devices) · 2026-03-04
- ModerateCulture media recalled over contamination that may darken the broth
FDA (Devices) · 2025-12-03
- HighBlood MacConkey biplates may carry Listeria monocytogenes surface contamination
FDA (Devices) · 2025-08-06
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02