MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD COR¿ MX; THERMAL CYCLER NUCLEIC ACID AMPLIFICATION ANALYSER IVD, LABORATORY

Catalog Number	443989
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported after using bd cor mx instrument, there was one false positive result on patient sample.The instrument reported positive for chlamydia, but the sample was retested the next day with a negative result.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
D2b.Medical device type: mkz, ouy, qep.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: the customer reported a discrepant result on cor mx, where a positive urine sample was repeated the next day, tested as negative.Service obtained r-files for review.Upon analysis, the discrepant result was close to the limit of detection for cycle threshold scores.This indicates that the sample had a low target load too close to the limit of detection.The second run did not show any amplification.The result was held during reprocessing.No returned part was available or expected as part of the investigation.The review did not indicate any instrument issue.This complaint is unconfirmed and the root cause is unknown.Dhr review is not required for this complaint as this complaint does not allege an early life failure or failure at installation and the configuration has changed since release for manufacturing due to service repairs/pms.Service history review for this instrument was completed and revealed related complaints related to this failure mode.Bd quality will continue to monitor for trends associated with the failure mode described in this complaint.Review of risk management files confirms there are no new or modified risks associated with this failure mode.
Event or Problem Description
It was reported after using bd cor mx instrument, there was one false positive result on patient sample.The instrument reported positive for chlamydia, but the sample was retested the next day with a negative result.No adverse impact was reported regarding the patient or user.

• Brand Name: BD COR¿ MX
• Common Device Name: THERMAL CYCLER NUCLEIC ACID AMPLIFICATION ANALYSER IVD, LABORATORY
• Manufacturer (Section D): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 24597677
• Report Number: 1119779-2026-00401
• Device Sequence Number: 18496109
• Product Code: LSL
• UDI-Device Identifier: 00382904439897
• UDI-Public: (01)00382904439897
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K210585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 443989
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown