MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH IH-1000 AUTOMATED ANALYZER SYSTEM

Catalog Number	001100
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial and final report on this incident.
Event or Problem Description
Ih-1000: false positive anti-b and control on ih-card abo/d(dvi-)+rev a1, b (ref.(b)(4), lot 9539020, expiry 1/25/2027).Tube testing was consistent with the patient being a positive.Trace analysis shows pipettor washing steps completed as expected.No errors noted during these steps.Card pipetting order performed in wells 4, 3, 2, and 1, which does not concur with inter-well carryover plausibility.The sample processed immediately prior (26ab-03b028) showed strong (++++) o positive reverse reactions.Given the strength of this reaction, there is a plausible risk of inter-sample carry-over, particularly if the previous sample had a high-titer anti-a.The similar unexpected agglutination pattern observed in both the control well and anti-b well supports this hypothesis.Conclusion: trace analysis shows pipettor washing steps completed as expected.No errors noted during these steps.Card pipetting order performed in wells 4, 3, 2, and 1, which does not concur with inter-well carryover plausibility.The sample processed immediately prior (26ab-03b028) showed strong (++++) o positive reverse reactions.Given the strength of this reaction, there is a plausible risk of inter-sample carry-over, particularly if the previous sample had a high-titer anti-a.The similar unexpected agglutination pattern observed in both the control well (4) and anti-b well (2) supports this hypothesis.

• Brand Name: IH-1000 AUTOMATED ANALYZER SYSTEM
• Common Device Name: IH-1000 AUTOMATED ANALYZER SYSTEM
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer Contact: monica albarca aguilera ; industriestrasse 1; dreieich, ; GM
• MDR Report Key: 24675246
• Report Number: 9610824-2026-00012
• Device Sequence Number: 10071296
• Product Code: KSZ
• UDI-Device Identifier: 07611969205493
• UDI-Public: (01)07611969205493
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: BK170019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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: 001100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/24/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IH-CARD ABO/D(DVI-)+REV A1, B, LOT 9539020.
• Patient Sex: Unknown