Lower riskMedical device recall · FDA · Published May 7, 2024
Becton Dickinson Recalls SARS-CoV-2 Reagents for False Negative RT-PCR Tests
Becton Dickinson recalls specific SARS-CoV-2 reagents for BD MAX systems due to potential false negative results from enzyme activity issues. Affected lots expire by August 2024.
“Becton Dickinson Recalls SARS-CoV-2 Reagents for False Negative RT-PCR Tests.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/55168-becton-dickinson-recalls-sars-cov-2-reagents-for-false-negative. Based on FDA recall #Z-2023-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2023-2024%22&limit=1).
The FDA announced on May 7, 2024, that Becton Dickinson & Co. is recalling BD SARS-CoV-2 Reagents for BD MAX Systems due to potential false negative results. The agency issued the recall after the firm identified decreased enzyme activity in the manufacturing process.
How to tell if you have it
BD SARS-CoV-2 Reagents for BD MAX" Systems
Catalog No. 445003-01
UPC 60382904450030
Lot No. 3291356 (Exp. 8/3/24)
Lot No. 3291358 (Exp. 11/19/24)
Lot No. 3326001 (Exp. 12/17/24)
The hazard
The assays may produce false negative results because of decreased activity of the enzyme utilized in manufacturing. The recall involves 2,061 kits distributed domestically and in Australia, Brazil, Belgium, Canada, Colombia, and Japan.
Context
GovInfoNow's records show Becton Dickinson & Co. has 43 other recalls on record since June 1, 2017. Other recent recalls of similar products include TECHNO-PATH Multichem ID-B Serum Recall (Oct. 17, 2025), Meridian Bioscience Revogene C. difficile Test Recall (Dec. 5, 2025), and BioFire Respiratory Panel 2.1 (June 24, 2026).
How to tell if you have this one
Check for the catalog number 445003-01 or the lot numbers 3291356 (expiring August 3, 2024), 3291358 (expiring November 19, 2024), or 3326001 (expiring December 17, 2024).
Brand
Becton Dickinson
Product
BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Reagent Lot Numbers
Identify the lot numbers on the reagent packaging to determine if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Domestic: Nationwide Distribution; Foreign: AU, BR, BE, CA, CO, & JP.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 36 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2023-2024 (May 7, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2023-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.