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.
Recall
- Recall Number
- Z-0525-2022
- Event Number
- 89329
- Firm
- Biomerieux Inc
- FEI Number
- 1950204
- Product Code
- JXB
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- December 20, 2021
- Terminated
- September 25, 2023
- Address
- 595 Anglum Rd, Hazelwood, MO, 63042-2320
Description
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.
Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.
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.
US (Domestic) Distribution to states of: AZ, IA, KY, and NY.
462 kits