BD PCR Cartridge 437519Recalls & reported problems

Becton, Dickinson And Company · BD PCR Cartridges 24EA · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This BD PCR cartridge, used with BD Max testing systems, has 140 adverse event reports, with no deaths or injuries. Nearly all describe false positive test results, where a sample tested positive when it was not. There is 1 recall, still open since December 2024, over possible signal drift in certain lots. No reports came in the last year, down from 133 in the year before.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 140
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 140 adverse event reports that list this exact device (DI 30382904375196), received between Jun 23, 2021 and Sep 3, 2025 — classified as 140 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (134 reports).

1 FDA recall record name this device's identifier, 1 still open.

6 other recalls cover devices cleared under the same FDA submission (K111860); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Dec 19, 2024Class IIOpen, Classified
Potential for signal drift in specific lots of BD PCR Cartridges.
Z-1004-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Device problems

False Positive Result134
Incorrect, Inadequate or Imprecise Result or Readings4
Contamination1
False Negative Result1

Patient problems

No Clinical Signs, Symptoms or Conditions140

Recent adverse event reports

The 25 most recent of 140 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 3, 2025Contamination; Contamination
IT WAS REPORTED WHILE USING BD BACTEC¿ FOS¿ CULTURE SUPPLEMENT KIT, THE CUSTOMER FOUND CONTAMINATION IN AN UNKNOWN QUANTITY OF MEDIA DURING QUALITY CONTROL TESTING. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22952953 ↗
MalfunctionSep 2, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD PCR CARTRIDGE, THERE WERE AN UNKNOWN NUMBER OF FALSE POSITIVE RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22948614 ↗
MalfunctionAug 27, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM, THERE WERE AN UNKNOWN NUMBER OF FALSE POSITIVE RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22902458 ↗
MalfunctionAug 11, 2025False Positive Result; False Positive Result
REPORT 2 OF 2: IT WAS REPORTED THAT DURING USE OF BD PCR CARTRIDGE ON BD MAX¿ INSTRUMENT, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. TEST WAS REPEATED ON MAX AND WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22777940 ↗
MalfunctionAug 11, 2025False Positive Result; False Positive Result
REPORT 1 OF 2: IT WAS REPORTED THAT DURING USE OF BD PCR CARTRIDGE ON BD MAX¿ INSTRUMENT, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. TEST WAS REPEATED ON MAX AND WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22777939 ↗
MalfunctionJul 23, 2025False Positive Result; False Positive Result
REPORT 5 OF 5: IT WAS REPORTED THAT DURING USE OF BD PCR CARTRIDGE ON BD MAX¿ INSTRUMENT, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. TEST WAS REPEATED USING A NEW CARTRIDGE, AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22580648 ↗
MalfunctionJul 23, 2025False Positive Result; False Positive Result
REPORT 3 OF 5: IT WAS REPORTED THAT DURING USE OF BD PCR CARTRIDGE ON BD MAX¿ INSTRUMENT, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. TEST WAS REPEATED USING A NEW CARTRIDGE, AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22580646 ↗
MalfunctionJul 23, 2025False Positive Result; False Positive Result
REPORT 4 OF 5: IT WAS REPORTED THAT DURING USE OF BD PCR CARTRIDGE ON BD MAX¿ INSTRUMENT, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. TEST WAS REPEATED USING A NEW CARTRIDGE, AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22580479 ↗
MalfunctionJul 23, 2025False Positive Result; False Positive Result
REPORT 1 OF 5: IT WAS REPORTED THAT DURING USE OF BD PCR CARTRIDGE ON BD MAX¿ INSTRUMENT, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. TEST WAS REPEATED USING A NEW CARTRIDGE, AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22580384 ↗
MalfunctionJul 23, 2025False Positive Result; False Positive Result
REPORT 2 OF 5: IT WAS REPORTED THAT DURING USE OF BD PCR CARTRIDGE ON BD MAX¿ INSTRUMENT, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. TEST WAS REPEATED USING A NEW CARTRIDGE, AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22580369 ↗
MalfunctionJun 26, 2025False Positive Result; False Positive Result
REPORT 11 OF 12: IT WAS REPORTED THAT DURING USE OF THE BD PCR CARTRIDGE ON BD MAX INSTRUMENT, A FALSE POSITIVE FLU A PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22341875 ↗
MalfunctionJun 26, 2025False Positive Result; False Positive Result
REPORT 7 OF 12: IT WAS REPORTED THAT DURING USE OF THE BD PCR CARTRIDGE ON BD MAX INSTRUMENT, A FALSE POSITIVE FLU A PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22341023 ↗
MalfunctionJun 26, 2025False Positive Result; False Positive Result
REPORT 8 OF 12: IT WAS REPORTED THAT DURING USE OF THE BD PCR CARTRIDGE ON BD MAX INSTRUMENT, A FALSE POSITIVE FLU A PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22336761 ↗
MalfunctionJun 26, 2025False Positive Result; False Positive Result
REPORT 10 OF 12: IT WAS REPORTED THAT DURING USE OF THE BD PCR CARTRIDGE ON BD MAX INSTRUMENT, A FALSE POSITIVE FLU A PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22336760 ↗
MalfunctionJun 26, 2025False Positive Result; False Positive Result
REPORT 2 OF 12: IT WAS REPORTED THAT DURING USE OF THE BD PCR CARTRIDGE ON BD MAX INSTRUMENT, A FALSE POSITIVE FLU A PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22336758 ↗
MalfunctionJun 26, 2025False Positive Result; False Positive Result
REPORT 6 OF 12: IT WAS REPORTED THAT DURING USE OF THE BD PCR CARTRIDGE ON BD MAX INSTRUMENT, A FALSE POSITIVE FLU A PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22336757 ↗
MalfunctionJun 26, 2025False Positive Result; False Positive Result
REPORT 3 OF 12: IT WAS REPORTED THAT DURING USE OF THE BD PCR CARTRIDGE ON BD MAX INSTRUMENT, A FALSE POSITIVE FLU A PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22336756 ↗
MalfunctionJun 26, 2025False Positive Result; False Positive Result
REPORT 4 OF 12: IT WAS REPORTED THAT DURING USE OF THE BD PCR CARTRIDGE ON BD MAX INSTRUMENT, A FALSE POSITIVE FLU A PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22336755 ↗
MalfunctionJun 26, 2025False Positive Result; False Positive Result
REPORT 9 OF 12: IT WAS REPORTED THAT DURING USE OF THE BD PCR CARTRIDGE ON BD MAX INSTRUMENT, A FALSE POSITIVE FLU A PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22336754 ↗
MalfunctionJun 26, 2025False Positive Result; False Positive Result
REPORT 12 OF 12: IT WAS REPORTED THAT DURING USE OF THE BD PCR CARTRIDGE ON BD MAX INSTRUMENT, A FALSE POSITIVE FLU A PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22336750 ↗
MalfunctionJun 26, 2025False Positive Result; False Positive Result
REPORT 5 OF 12: IT WAS REPORTED THAT DURING USE OF THE BD PCR CARTRIDGE ON BD MAX INSTRUMENT, A FALSE POSITIVE FLU A PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22336749 ↗
MalfunctionJun 24, 2025False Negative Result; False Negative Result
IT WAS REPORTED THAT DURING USE OF BD CTGCTV2 FOR BD MAX¿ SYSTEM, A FALSE NEGATIVE GONORRHOEAE PATIENT RESULT WAS OBTAINED. THE PATIENT'S URETHRAL SAMPLE WAS TAKEN ON ESWAB AND TRANSFERRED TO BD MAX TUBE. ON THE FIRST RUN A SINGLE GC TARGET WAS AMPLIFIED BUT WITH AN UNUSUAL PCR CURVE. SAMPLE WAS CULTURED AND WAS POSITIVE. DIRECT EXAMINATION (GRAM) ALSO REVEALED THE PRESENCE OF A GONOCOCCUS. SAMPLE WAS RUN ON A BRUCKER MALDI TOFF, ALSO CONFIRMING THE PRESENCE OF GONOCOCCUS. SAMPLE WAS RUN AGAIN DILUTED AND UNDILUTED ON BD MAX, BOTH WITH POSITIVE RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22323031 ↗
MalfunctionJun 18, 2025False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE OF BD PCR CARTRIDGE ON THE BD MAX¿ INSTRUMENT, AN UNSPECIFIED NUMBER OF FALSE POSITIVE PATIENT RESULTS WITH UNUSUAL PCR CURVES WERE OBTAINED. POSITIVE RESULTS WERE RETESTED AND WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22287635 ↗
MalfunctionMay 1, 2025False Positive Result; False Positive Result
REPORT 9 OF 9: IT WAS REPORTED THAT DURING USE OF THE BD PCR CARTRIDGE ON BD MAX INSTRUMENT, A FALSE POSITIVE FLU A PATIENT RESULT WAS OBTAINED. SAMPLE WAS REPEATED ON MAX AND WAS FLU A NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21944919 ↗
MalfunctionApr 30, 2025False Positive Result; False Positive Result
REPORT 2 OF 2: IT WAS REPORTED THAT DURING USE OF BD PCR CARTRIDGE ON BD MAX¿ INSTRUMENT, 8 FALSE POSITIVE CAMPLYOBACTER PATIENT RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21937944 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111860. One submission often covers many models, so check the product and lot details in each record.

Z-0238-2026 · Sep 23, 2025 · Open, Classified
BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.
Z-0590-2025 · Oct 31, 2024 · Open, Classified
BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
Z-1864-2017 · Jul 29, 2015 · Terminated
Software version 4.44A utilized on the BD MAX System
Z-1662-2013 · May 31, 2013 · Terminated
BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification a
Z-0976-2013 · Dec 11, 2012 · Terminated
BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada
Z-0701-2013 · Sep 18, 2012 · Terminated
Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.

Device details

UDI-DI	`30382904375196`
Brand	BD PCR Cartridge
Model	437519
Company	Becton, Dickinson And Company
Product code	OOI · real time Nucleic acid amplification system
Class	Class 2
FDA submission	K111860
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 14, 2025

Device type (GMDN): Thermal cycler nucleic acid amplification analyser IVD, laboratory

An electrically-powered automated or semi-automated laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or quantified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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