The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1004-2025·Announced 2025-01-29

BD PCR Cartridges for MAX System signal drift in select lots

Specific lots of BD PCR Cartridges used with the MAX System may experience signal drift, potentially affecting diagnostic accuracy. BD has initiated a recall of 516,435 affected units worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall affecting diagnostic accuracy. The source text describes a potential for signal drift with no reported illnesses or injuries, making the hazard theoretical rather than confirmed. Per the rubric, recalls with theoretical risks and no reported harm typically score at a maximum of 3 (High).

Plain-English summary

Becton Dickinson & Co. is recalling specific lots of BD PCR Cartridges (Model 437519) used with the MAX System. A total of 516,435 units have been identified as part of this recall, which affects cartridges distributed worldwide and throughout the United States.

The recall addresses a potential for signal drift in these cartridges. Signal drift means the cartridge readings may become inaccurate or unreliable over time, which could affect the accuracy of diagnostic test results.

The affected cartridges were distributed to healthcare facilities, laboratories, and diagnostic centers worldwide, including facilities in numerous U.S. states and countries such as Canada, Australia, Japan, India, and others.

Customers who have received these cartridges should contact Becton Dickinson & Co. for instructions on how to identify affected units and for guidance on appropriate next steps. Healthcare providers should consult with their laboratory directors regarding any necessary actions to ensure diagnostic accuracy.

The recalled product

Product
BD PCR Cartridges used with MAX System. Model Number: 437519
Manufacturer
Becton Dickinson & Co.
Category
Medical Device — Diagnostic Equipment
Hazard
Affected units
516,435

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model Number: 437519. UDI Numbers: (01)30382904375196(17)261205(10)4323345
  • (01)30382904375196(17)261129(10)4317725
  • (01)30382904375196(17)261122(10)4309022
  • (01)30382904375196(17)261115(10)4302135
  • (01)30382904375196(17)261111(10)4296086
  • (01)30382904375196(17)261104(10)4289593
  • (01)30382904375196(17)261029(10)4281532
  • (01)30382904375196(17)261021(10)4275828
  • (01)30382904375196(17)261014(10)4268747
  • (01)30382904375196(17)261007(10)4254714
  • (01)30382904375196(17)260930(10)4254710
  • (01)30382904375196(17)260923(10)4247089
  • (01)30382904375196(17)260913(10)4239079
  • (01)30382904375196(17)260909(10)4233297
  • (01)30382904375196(17)260902(10)4225364
  • (01)30382904375196(17)260826(10)4204545
  • (01)30382904375196(17)260805(10)4198065
  • (01)30382904375196(17)260729(10)4191581
  • (01)30382904375196(17)260722(10)4185634
  • (01)30382904375196(17)260716(10)4178328

Distribution

Distributed nationwide across the United States.

The notice also names 48 states specifically:

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