Lower riskMedical device recall · FDA · Published March 24, 2021
Becton Dickinson BioGX SARS-CoV-2 Reagents for BD MAX System: Unsealed Tubes Risk False
Becton Dickinson recalls BioGX SARS-CoV-2 Reagents for BD MAX System PCR tests due to unsealed rehydration buffer tubes that may cause false negative results. Affected lots listed in the recall.
BioGX SARS-CoV-2 Reagents for BD MAX" System rehydration buffer tubes were not adequately sealed causing some tubes to be partially filled or empty upon use. A partially filled or empty rehydration buffer tube may lead to an Unresolved (UNR) result on the BD MAX" System
Becton Dickinson is recalling BioGX SARS-CoV-2 Reagents for BD MAX System PCR tests because some rehydration buffer tubes weren't sealed properly. This could lead to false negative results on the test, meaning the test might show no infection when there is one. Read more at govinfonow.com/recall/62989-becton-dickinson-biogx-sars-cov-2-reagents-for-bd-max.
“Becton Dickinson BioGX SARS-CoV-2 Reagents for BD MAX System: Unsealed Tubes Risk False.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62989-becton-dickinson-biogx-sars-cov-2-reagents-for-bd-max. Based on FDA recall #Z-1416-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1416-2021%22&limit=1).
The FDA announced on March 24, 2021, that Becton Dickinson & Co. is recalling BioGX SARS-CoV-2 Reagents for the BD MAX System due to sealing defects in rehydration buffer tubes. The agency said the defect may cause unresolved test results. Owners should contact the company for a remedy.
How to tell if you have it
Brand: Becton Dickinson
Product: BioGX SARS-CoV-2 Reagents for BD MAX System
Catalog Number: 444213
Lot Numbers: K20-347 through K20-643 (see record for full list)
Expiration Dates: 1/23/2021 through 5/17/2021
UDI: 382904442132
Units affected: 21,529 Kits
Distribution: US Nationwide
The hazard
The rehydration buffer tubes were not adequately sealed, causing some to be partially filled or empty upon use. A partially filled or empty tube may lead to an Unresolved (UNR) result on the BD MAX System.
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 the BD GasP: CO2 Pouch System Recall (April 7, 2026), the BD Kiestra Isolate Suspension Cuvette Array recall (Oct. 23, 2025), and the Becton Dickinson & Co. Product Catalog recall (Sept. 23, 2025). Other recent recalls of similar products include the Biomerieux VITEK 2 AST-N447 Kit Recall (June 4, 2026), the Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026), and the Medline Blood Culture Kit Recall (Dec. 24, 2025).
How to tell if you have this one
Check the lot numbers and expiration dates listed in the recall: K20-347 through K20-639 with expiration dates from January 23, 2021 to May 13, 2021. The product is for PCR testing of SARS-CoV-2 in nasopharyngeal specimens.
Brand
Becton Dickinson
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Review the lot number and expiration date on the reagent packaging to confirm if it's in the affected list.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-1416-2021 (March 24, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1416-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.