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U.S. Department of Health and Human Services

Class 2 Device Recall VIDAS

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  Class 2 Device Recall VIDAS see related information
Date Initiated by Firm September 22, 2021
Create Date December 28, 2021
Recall Status1 Open3, Classified
Recall Number Z-0424-2022
Recall Event ID 88797
Product Classification Radioimmunoassay, progesterone - Product Code JLS
Product VIDAS PRG Progesterone, REF 30409-01
Code Information UDI 03573026064952, Lot #s: 1008685490, 1008766980, 1008775630, 1008873180, 1008911240
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact Brian Armstrong
919-620-2000
Manufacturer Reason
for Recall		 bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action For products with No remaining shelf life (taking into account the revised expiration date): - Identify impacted lots - Stop using the listed impacted lots - Destroy the remaining impacted lots in your inventory For products with remaining shelf life (taking into account the revised expiration date): - Identify impacted products and lots listed - Update product expiration date per your internal procedures of the remaining usable lots to meet the new revised expiration date specified in Table 1 - Continue product use until the revised expiration date. Consignees are asked to distribute this information to all appropriate personnel in their laboratory, retain a copy in their files, and forward this information to all parties that may use this product, including others to whom you may have transferred affected product. Complete the Acknowledgement Form in Attachment A and return it to USFieldActions@biomerieux.com or Fax to: (919) 620-3306 to confirm receipt of this notice.
Quantity in Commerce 1818 units
Distribution US Nationwide distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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