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U.S. Department of Health and Human Services

Class 2 Device Recall BD COR System Software

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 Class 2 Device Recall BD COR System Softwaresee related information
Date Initiated by FirmJune 23, 2025
Date PostedJuly 23, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2162-2025
Recall Event ID 97142
PMA NumberP160037 
Product Classification Kit, dna detection, human papillomavirus - Product Code MAQ
ProductBD COR System Software. Model Number: 444829.
Code Information Model Number: 444829. UDI-DI: 00382904448295. Software version 8.80 and above.
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information ContactJeffrey Zinza
410-316-4000
Manufacturer Reason
for Recall		Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
FDA Determined
Cause 2		Under Investigation by firm
ActionBecton, Dickinson and Company began notification of consignees on about 06/23/2025 via telephone call and followed by a letter. Consignees were instructed to note the outlined workflows when loading specimens with the Over labeling feature enabled and consider retesting affected specimens for HPV testing if affected. Consignees were also instructed to post the notification within their facility, notify customers if affected units were further distributed, and complete and return the provided Customer Response Form.
Quantity in Commerce7 systems
DistributionWorldwide - US Nationwide distribution in the states of Florida, Texas and Michigan. The countries of Sweden and Belgium.
Total Product Life CycleTPLC 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.
PMA DatabasePMAs with Product Code = MAQ
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