MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B; IH-CARD ABO/D(DVI-)+REV A1,B; 288 CARDS

Catalog Number	813112100
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported a false positive anti-b result with ih-card abo/d(dvi-)+rev a1, b when testing on their ih-1000 instrument.A patient sample was tested in duplicate.The anti-b was initially 1 positive but negative when repeated using the same instrument and reagents.The trace files of the affected instrument were collected for investigation.The investigation is still ongoing.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported a false positive anti-b result with ih-card abo/d(dvi-)+rev a1,b when testing on their ih-1000 instrument.A patient sample was tested in duplicate.The anti-b was initially 1 positive but negative when repeated using the same instrument and reagents.The trace files of the affected instrument were collected for investigation.The snapshots provided didn't shows any issue concerning this samples.The user perfomed testing with the yellow well and noticed the same false-positive results.The issue could not be reproduced by the manufacturer.We also checked the ih-liss retention samples in dreieich, and among the 34 boxes currently in the reference stock, no wells with abnormal coloration were observed.This leads us to believe that this is an isolated case, and we are not able to link it to manufacturing.Resolution: for ih-liss, it is specifically indicated not to use the product in case of turbidity; this also applies when there are visible color differences in the wells.In this context, our recommendation is to visually check the ih-]liss before loading it onto the devices, and if any turbidity or discoloration is observed, testing with that rack should not be performed.If this situation occurs again, the rack should be returned unused to bio-rad dreiech so that we can perform further analyses.

• Brand Name: BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B
• Common Device Name: IH-CARD ABO/D(DVI-)+REV A1,B; 288 CARDS
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer Contact: monica albarca ; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 24362188
• Report Number: 9610824-2026-00005
• Device Sequence Number: 5066434
• Product Code: QHR
• UDI-Device Identifier: 07611969964529
• UDI-Public: (01)07611969964529(17)270127(10)9539020
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: 125534
• 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,Followup
• 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: 813112100
• Device Lot Number: 9539020
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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-1000, SN (B)(6); IH-1000, SN (B)(6)
• Patient Sex: Unknown