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.
The rehydration buffer tubes were not sealed adequately, which can cause some tubes to be partially filled or empty when used. This may lead to an Unresolved (UNR) result on the BD MAX System, meaning the test might show a negative result when the person is actually infected.
Users of the BioGX SARS-CoV-2 Reagents for BD MAX System PCR tests who purchased the affected lots between January 2021 and May 2021 are likely impacted. Laboratory personnel and healthcare providers using these reagents are most at risk.
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.
Review the lot number and expiration date on the reagent packaging to confirm if it's in the affected list.
The rehydration buffer tubes were not sealed properly, which can cause some tubes to be partially filled or empty when used, leading to false negative results on the BD MAX System.
The recall does not specify a remedy, so there is no action required beyond checking if your product is affected.
Check the lot number and expiration date on the packaging. Affected lots range from K20-347 to K20-639 with expiration dates from January 23, 2021 to May 13, 2021.
We’ve drafted a message you can send Becton Dickinson to request your refund or repair — edit it as you like.
Subject: Recall Z-1416-2021 — Becton Dickinson Becton Dickinson Hello, I own a Becton Dickinson that is covered by recall Z-1416-2021 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.
