Becton Dickinson recalls 30-test SARS-CoV-2 & Flu A+B rapid tests due to unapproved instructions causing false positive/negative results, risking delayed diagnosis and treatment.
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 is recalling 30 single-use test devices for SARS-CoV-2 and flu A+B detection because the instructions for use (IFU) are not FDA-approved. This could lead to false test results, which might delay proper diagnosis or treatment of infections.
The test kits come with instructions that haven't been approved by the FDA. Using them with incorrect specimen types could produce false positive or false negative results. This might cause delays in diagnosing infections, which could affect patient care.
Healthcare professionals and labs using the BD Veritor System for rapid testing are most at risk. The recall affects specific batches of the test kits sold between 2023 and 2024.
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.
Look for the catalog number (e.g., 256088) or expiration date (e.g., 01-06-23) on the test kit packaging.
The instructions for use (IFU) are not FDA-approved, which could cause false positive or false negative results when using the test with invalid specimen types.
The recall record does not specify a remedy, so no action is required beyond checking if you have the affected product.
The recall does not mention any physical injury risk; the hazard is limited to potential false test results that could delay diagnosis.
We’ve drafted a message you can send Becton Dickinson to request your refund or repair — edit it as you like.
Subject: Recall Z-1682-2023 — Becton Dickinson Becton Dickinson Hello, I own a Becton Dickinson that is covered by recall Z-1682-2023 from Becton Dickinson. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
