Becton Dickinson recalls specific SARS-CoV-2 reagents for BD MAX systems due to potential false negative results from enzyme activity issues. Affected lots expire by August 2024.
Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.
Becton Dickinson is recalling certain SARS-CoV-2 reagents for BD MAX systems because they may produce false negative results. This could lead to incorrect test outcomes, especially if the enzyme used in manufacturing has decreased activity.
The reagents may produce false negative results because the enzyme used in manufacturing has decreased activity. This could lead to incorrect test outcomes where the virus is not detected when it is actually present.
Healthcare professionals using the BD MAX system with the recalled reagents. Those testing for SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swabs or saliva may be affected.
Check for the catalog number 445003-01 or the lot numbers 3291356 (expiring August 3, 2024), 3291358 (expiring November 19, 2024), or 3326001 (expiring December 17, 2024).
Identify the lot numbers on the reagent packaging to determine if it is affected.
The reagents may produce false negative results due to decreased activity of the enzyme used in manufacturing.
Check the lot numbers on the reagent packaging to see if it is affected. If it is, contact Becton Dickinson for instructions.
The recall is for potential false negative results, not a safety hazard. There is no risk of injury from using the reagents.
We’ve drafted a message you can send Becton Dickinson to request your refund or repair — edit it as you like.
Subject: Recall Z-2023-2024 — Becton Dickinson Becton Dickinson Hello, I own a Becton Dickinson that is covered by recall Z-2023-2024 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.
