Z-0525-2022Class II

API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the...

Name: Z-0525-2022 API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the...
Creator: Biomerieux Inc
Published: 2021-12-20
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2021-12-20 / Terminated / root cause: manufacturing process

FDA source

Biomerieux Inc began a recall of API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests... on 2021-12-20. FDA classified it as Class II and gives the reason as "Risk of misidentification or delayed results with the absence of identification due to thermoforming defect". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0525-2022
Classification: Class II
Status: Terminated
Initiated: 2021-12-20
Posted: 2022-01-25
Terminated: 2023-09-25
Recalling firm: bioMerieux, Inc.
Product: API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests as well as a specially adapted database. After manual inoculation of the strip, reading can be performed either automatically or manually and the identification is obtained using an identification software.
Product code: JXB Kit, Identification, Yeast
Reason for recall: Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm, bioMrieux, sent an "URGENT FIELD SAFETY NOTICE," to customers on 01/13/2022 informing customers of the recall and the potential for the shape of the API ID 32 C Reference 32200. Customers are asked to inform their laboratory staff of the recall notification, retain a copy for their files, and forward on the notice to any entity to which the product was further distributed. Biomerieux indicated that customers may use the product if the wells are cylindrically shaped but must stop using and destroy any product displaying the microcupule wells. The firm asks that customers contact bioMerieux's Industry Customer Service department at (800)634-7656 (option 1) or email [email protected] to require a replacement or credit for discarded product. Additionally, the firm states that for tests previously performed using the recalled product, they recommend that customers identify any possible misidentifications, analyze the risks related to this recall notification, and determine the appropriate actions. An acknowledgement form was provided with the recall notice and should be returned to the firm, completed, by email at [email protected] or fax at (919)620-3306. If you require additional assistance or have any questions, please contact your local bioMrieux Industry Customer Service Representative at (800) 634-7656. For non-urgent inquiries, please contact the Industry Technical Support Center by email at [email protected]. The anticipated turnaround time for email inquiries is 24 48 hours during normal business hours (7AM 7PM EST), and up to 72 hours dependent upon weekends and company observed holidays.
Quantity in commerce: 462 kits
Distribution: US (Domestic) Distribution to states of: AZ, IA, KY, and NY.
Product codes and lots: Model No. 32200; Lot 1008781060.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0525-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0525-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-02	2022-01-25

Product code JXB

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)