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U.S. Department of Health and Human Services

Class 2 Device Recall BD SARSCoV2 Reagents for BD MAX" Systems

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 Class 2 Device Recall BD SARSCoV2 Reagents for BD MAX" Systemssee related information
Date Initiated by FirmMay 07, 2024
Date PostedJune 05, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2023-2024
Recall Event ID 94599
Product Classification Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
ProductBD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swab specimens, and saliva specimens.
Code Information Catalog No. 445003-01; UDI-DI: (01) 60382904450030 (17) 240803 (10) 3291356 (20) 01 (30) 1, (01) 60382904450030 (17) 241119 (10) 3291358 (20) 01 (30) 1, (01) 60382904450030 (17) 241217 (10) 3326001 (20) 01 (30) 1; Lot No. 3291356 (Exp. 8/3/24), 3291358 (Exp. 11/19/24), 3326001 (Exp. 12/17/24).
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
Manufacturer Reason
for Recall		Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.
FDA Determined
Cause 2		Component design/selection
ActionConsignees were mailed and/or emailed an URGENT: Medical Device Product Correction notification, dated 5/7/24. The notification instructs consignees to immediately inspect their inventory for affected devices and destroy them per the consignee's destruction process, ensure the notification is read and understood, disseminate the notification to among those in your organization and customers who should be made aware, and return the completed Response Form to BD by email to BDRC22@bd.com or by fax to 312-949-0438. Consignees with any complaints can call 1-844-823-5433 or email productcomplaints@bd.com; consignees with any recall related questions can email BDRC22@bd.com.
Quantity in Commerce2,061 kits
DistributionDomestic: Nationwide Distribution; Foreign: AU, BR, BE, CA, CO, & JP.
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.
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