Becton Dickinson recalls BioGX SARS-CoV-2 Reagents for BD MAX System (catalog 444213) due to mislabeled N1/N2 pouches. This could cause false negatives in SARS-CoV-2 tests, risking missed diagnoses and spread of COVID-19.
Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MAX System may be mislabeled. This could result in a kit containing two pouches of N1 master mix or two pouches of N2 master mix, instead of one pouch of each. If laboratory personnel do not notice that both pouches contain tubes with the same color foil seal and use two of the same tubes, there is a low potential for a false negative SARS-CoV-2 result. A false negative SARS-CoV-2 result could lead to an increased risk of disease progression for the patient and additional spread of SARS-CoV-2 if the patient is not quarantined.
Becton Dickinson is recalling BioGX SARS-CoV-2 Reagents for BD MAX System (catalog 444213) because some pouches may be mislabeled, leading to false negative test results. This could mean a patient isn't properly diagnosed and might spread COVID-19 without knowing.
The reagents may contain two pouches of the same type (N1 or N2) instead of one pouch each due to mislabeling. If lab staff use both pouches of the same type without noticing the color seal, the test might give a false negative result, meaning the test shows no infection when there is one. This could lead to patients not being quarantined and spreading COVID-19.
Laboratory personnel using the BioGX SARS-CoV-2 Reagents for BD MAX System with catalog number 444213. Those most at risk are healthcare providers handling the reagents in labs where false negatives could lead to undetected infections.
Check for catalog number 444213 and lot numbers K20-507, K20-508, K20-509, K20-516, K20-517, K21-020, or K21-021 on the reagent packaging. The reagents are used in labs for SARS-CoV-2 testing via BD MAX System.
Look for catalog number 444213 and lot numbers K20-507 through K21-021 on the reagent packaging.
Using mislabeled reagents could cause a false negative SARS-CoV-2 test result, meaning the test might show no infection when there is one. This could lead to undetected infections and potential spread of COVID-19.
No, the recall does not require stopping use immediately. Laboratory personnel should check labels to ensure they are using the correct mix of pouches.
The recalled reagents have catalog number 444213 and lot numbers K20-507, K20-508, K20-509, K20-516, K20-517, K21-020, or K21-021.
We’ve drafted a message you can send Becton Dickinson to request your refund or repair — edit it as you like.
Subject: Recall Z-0954-2021 — Becton Dickinson Becton Dickinson Hello, I own a Becton Dickinson that is covered by recall Z-0954-2021 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.
