Becton Dickinson recalls BD MAX SARS-CoV-2 Reagents due to potential false positive results that could delay diagnosis and increase COVID-19 exposure risk. All units affected.
BD is experiencing elevated rates of potential false positive results from certain customers when using the BD SARS-CoV-2 Reagents for the BD MAX System. False positive test results could lead to a delay in diagnosis and potentially cause the patient to be exposed to COVID-19 if they are isolated with an infected individual.
Becton Dickinson is recalling SARS-CoV-2 reagents for the BD MAX System because they may cause false positive test results. This could delay diagnosis and lead to patients being exposed to COVID-19 if isolated with infected individuals.
The reagents may produce false positive results when used with certain customers' equipment. False positives could delay proper diagnosis and cause patients to be exposed to COVID-19 if they are isolated with infected individuals.
Healthcare providers using the BD MAX SARS-CoV-2 Reagents for COVID-19 testing are affected. Patients who receive false positive results may be incorrectly isolated with infected individuals.
Check for product labels with the catalog number 445003 or 445003-01. All lots of these reagents are affected, so no specific purchase date is needed.
Look for the catalog number 445003 or 445003-01 on the reagent packaging.
No, the recall does not require stopping use. The reagents are affected but no specific remedy is stated.
False positives could delay diagnosis and lead to patients being exposed to COVID-19 if incorrectly isolated with infected individuals.
Yes, all lots of the BD MAX SARS-CoV-2 Reagents with catalog numbers 445003 and 445003-01 are affected.
We’ve drafted a message you can send Becton Dickinson to request your refund or repair — edit it as you like.
Subject: Recall Z-2754-2020 — Becton Dickinson Becton Dickinson Hello, I own a Becton Dickinson that is covered by recall Z-2754-2020 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.
