MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® TAQMAN® 96 ANALYZER; ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE

Catalog Number	03121453001
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number is m17138.The expiration date was requested but not provided.The investigation determined that the issue was due to environmental contamination within the laboratory or on instrument surfaces.The contamination issue was resolved following an intensive cleaning protocol, with no new pp6 reactive results reported.The investigation confirmed the instruments functioned as intended with no detected mechanical errors.
Event or Problem Description
There was an allegation of questionable results with donor patient samples using the cobas® taqscreen mpx test, version 2.0, tested on a cobas® taqman® 96 analyzer.On (b)(6) 2025: a primary pool of 6 (pp6) was reactive for hbv, and the repeat as a resolution of 1 was non-reactive.On (b)(6) 2025: a primary pool of 6 (pp6) was reactive for hbv, and the repeat as a resolution of 1 was non-reactive.On (b)(6) 2026: a primary pool of 6 (pp6) was reactive for hbv, and the repeat as a resolution of 1 was non-reactive.On (b)(6) 2026: a primary pool of 6 (pp6) was reactive for hbv, and the repeat as a resolution of 1 was non-reactive.The non-reactive results were released.

• Brand Name: COBAS® TAQMAN® 96 ANALYZER
• Common Device Name: ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer (Section G): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250 ; 9253534412
• MDR Report Key: 24135371
• Report Number: 2243471-2026-00235
• Device Sequence Number: 10344465
• Product Code: JJF
• UDI-Device Identifier: 04015630925537
• UDI-Public: 04015630925537
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K012966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2026

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: Health Professional
• Device Catalogue Number: 03121453001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown