—#191284

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.

FDA product code: JXB — Kit, Identification, Yeast
Device class: Class 1
Medical specialty: Microbiology
Affected lot / code info: Model No. 32200; Lot 1008781060.

Why it was recalled

Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.

Root cause (FDA determination)

Employee error

Action the firm took

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 customerservice-indorders@biomerieux.com 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 USFieldActions@biomerieux.com 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 SI.STL@biomerieux.com. 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.

Recalling firm

Firm: Biomerieux Inc
Address: 595 Anglum Rd, Hazelwood, Missouri 63042-2320

Distribution

Distribution pattern: US (Domestic) Distribution to states of: AZ, IA, KY, and NY.

Timeline

Recall initiated: 2021-12-20
Terminated: 2023-09-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #191284. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.