Z-0530-2014Class II

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

Name: Z-0530-2014 remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of RapID Yeast Plus...
Creator: Remel Inc
Published: 2013-04-04
License: https://open.fda.gov/license/

Remel Inc / initiated 2013-04-04 / Terminated / root cause: labeling and UDI

FDA source

Remel Inc began a recall of 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... on 2013-04-04. FDA classified it as Class II and gives the reason as "The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The labels were reversed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0530-2014
Classification: Class II
Status: Terminated
Initiated: 2013-04-04
Posted: 2013-12-17
Terminated: 2014-03-12
Recalling firm: Remel Inc
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.
Product code: JXB Kit, Identification, Yeast
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: 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).
Quantity in commerce: 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.
Product codes and lots: Lot 302532, Exp 6 Feb 2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0530-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0530-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-17

Product code JXB

K943621Class IRapid Yeast Plus SystemInnovative Diagnostic Systems, Inc. / cleared 1995-01-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)