Date Initiated by Firm | September 30, 2021 |
Create Date | November 17, 2021 |
Recall Status1 |
Terminated 3 on January 18, 2024 |
Recall Number | Z-0243-2022 |
Recall Event ID |
88844 |
Product Classification |
Culture media, general nutrient broth - Product Code JSC
|
Product | API 50 CH, Model 50300 |
Code Information |
Model 50300, Lot 1008679230 UDI: (01)03573026087401 (17)220330 (10)1008679230 |
Recalling Firm/ Manufacturer |
bioMerieux, Inc. 100 Rodolphe St Durham NC 27712-9402
|
For Additional Information Contact | bioMerieux Customer Service Center 919-620-2000 |
Manufacturer Reason for Recall | There is potential to provide an incorrect organism identification. |
FDA Determined Cause 2 | Material/Component Contamination |
Action | Notification letters were issued to customers via FedEx Priority Overnight mail during the week of October 4, 2021.
Customers are asked to do the following:
-Discontinue use of and discard any remaining inventory of lot 1008679230.
-For tests previously performed using API 50 CH Ref. 50300 lot# 1008679230, we
are asking you to identify any possible incorrect identification test result due to a
false positive reaction of test 34, analyze the related risks and to determine
appropriate actions, if relevant.
-Complete the Acknowledgement Form in Attachment A and return it to your local
bioMrieux representative to confirm receipt of this notice.
-Distribute this information to all appropriate personnel in the laboratory, retain a
copy in your files.
-Contact your local bioMrieux representative for product compensation.
Consignees will perform destruction activities at their site. |
Quantity in Commerce | 1382 kits |
Distribution | Distribution in WI, NY, and SD |
Total Product Life Cycle | TPLC Device Report |
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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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