IFU- Instructions for Use (IFU) package insert and both the IFU packaged with the test kit and the electronic version on the BD website not approved by FDA,specifically describing specimen type, could cause use of the test with invalid specimen types, which may produce false positive or false negative results.Erroneous results can cause a delay in diagnosis or treatment
“Becton Dickinson Veritor System Recall: False Test Results Risk Diagnosis Delay.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58484-becton-dickinson-veritor-system-recall-false-test-results-risk-diagnosis. Based on FDA recall #Z-1682-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1682-2023%22&limit=1).
The FDA announced on May 1, 2023, that Becton Dickinson & Co. is recalling BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B test devices because unapproved instructions could lead to false positive or negative results. The agency issued recall number Z-1682-2023 for the voluntary Class II recall.
How to tell if you have it
Brand: Becton Dickinson
Product: BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices
Distribution: US Nationwide and the countries of CA, CL, HK, TW
The hazard
The Instructions for Use package insert and electronic version on the BD website were not approved by the FDA and specifically described specimen types. This error could cause use of the test with invalid specimen types, which may produce false positive or false negative results. Erroneous results can cause a delay in diagnosis or treatment.
Context
GovInfoNow's records show Becton Dickinson & Co. has 43 other recalls on record since 2017-06-01. Other recent recalls of similar products include BD GasPak EZ Campy Pouch System Recall (2026-04-07), BD Kiestra Isolate Suspension Cuvette Array Recall (2025-10-23), and BD MAX System Recall (2025-09-23). Other recent recalls of similar products include Becton Dickinson Spinal Tray Recall (2026-04-27), Biomerieux VITEK 2 AST-N461 Test Kit Recall (2026-07-24), and Vivoo Protein Test Recall (2025-11-22).
How to tell if you have this one
Check for the catalog number on the test kit (e.g., 256088, 2077698) or the expiration date (e.g., 01-06-23). The product is sold as a 30-test device for in vitro testing of SARS-CoV-2 and flu A+B.
Brand
Becton Dickinson
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the catalog number (e.g., 256088) or expiration date (e.g., 01-06-23) on the test kit packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of CA, CL, HK, TW.” 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 44 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-1682-2023 (May 1, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1682-2023 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.