Becton Dickinson recalls BD PCR Cartridges (model 437519) with potential signal drift in specific lots. Affected units have unique UDI numbers listed in the recall notice.
Potential for signal drift in specific lots of BD PCR Cartridges.
Becton Dickinson is recalling specific lots of BD PCR Cartridges used with the MAX System due to potential signal drift. This could lead to inaccurate test results if the cartridges are used without proper calibration.
Signal drift in these specific lots can cause inaccurate test results when used with the MAX System. This may lead to incorrect conclusions in laboratory testing if the cartridges are not properly calibrated.
Users of BD PCR Cartridges with model number 437519 who have the specific UDI numbers listed in the recall notice are affected. Laboratory technicians and researchers using these cartridges are most at risk of inaccurate test results.
Check if your BD PCR Cartridges have model number 437519 and the specific UDI numbers listed in the recall notice. The UDI numbers follow the format (01)30382904375196(17)XXXXXX(10)XXXXXX.
Verify your BD PCR Cartridge model number is 437519.
Check if your cartridge has one of the specific UDI numbers listed in the recall notice.
Becton Dickinson has identified potential signal drift in specific lots of BD PCR Cartridges, which could lead to inaccurate test results when used with the MAX System.
Check if your cartridge has model number 437519 and one of the specific UDI numbers listed in the recall notice.
The recall notice does not specify a remedy, so affected users should contact Becton Dickinson directly for guidance.
We’ve drafted a message you can send Becton Dickinson to request your refund or repair — edit it as you like.
Subject: Recall Z-1004-2025 — Becton Dickinson Becton Dickinson Hello, I own a Becton Dickinson that is covered by recall Z-1004-2025 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.