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U.S. Department of Health and Human Services

Class 2 Device Recall Kit, Identification, Yeast

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  Class 2 Device Recall Kit, Identification, Yeast see related information
Date Initiated by Firm December 20, 2021
Create Date January 25, 2022
Recall Status1 Terminated 3 on September 25, 2023
Recall Number Z-0525-2022
Recall Event ID 89329
Product Classification Kit, identification, yeast - Product Code JXB
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.
Code Information Model No. 32200; Lot 1008781060.
Recalling Firm/
Manufacturer		 Biomerieux Inc
595 Anglum Rd
Hazelwood MO 63042-2320
For Additional Information Contact bioMerieux Customer Service Center
800-682-2666
Manufacturer Reason
for Recall		 Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.
FDA Determined
Cause 2		 Employee error
Action The firm, bioM¿rieux, 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 bioM¿rieux 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.
Quantity in Commerce 462 kits
Distribution US (Domestic) Distribution to states of: AZ, IA, KY, and NY.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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