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U.S. Department of Health and Human Services

Class 2 Device Recall API 50 CH

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  Class 2 Device Recall API 50 CH see related information
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 bioM¿rieux 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 bioM¿rieux 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
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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