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 Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our combined initial and final report on this incident.
Event or Problem Description
Customer reported false positive anti-b on 2 samples.Testing was performed using ih-1000 with ih-card abo/d(dvi-)+rev a1,b lot 9535010, samples (b)(6) were tested in duplicate.The false positive anti-b reaction interpretations appear justified.Both samples were repeated on the same instrument and also tested by tube method.Repeat testing for both samples was o positive.The shipment for the abo cards was received 12/1/2025 and there were (b)(4) boxes.They have 9 boxes remaining.The customer removed the abo cards from the instrument and did see some reagent splashes, specifically in the anti-d wells.They spun them down and they looked better, so they are back in use.Customer is a long time user that is aware of ifu instructions for storage and handling of cards.Investigation: no other complaints for this lot registered.The production batch records were checked, and all manufacturing/qc records are compliant, and there are no manufacturing-related quality concerns.The cards of the retention sample were visually checked for the sealing foil, the presence of supernatant, and gel homogeneity, and showed no abnormalities.Serological tests were performed using known a+ and b+ samples.The tests were carried out on ih-1000.All reactions were specific; no false positive reactions occurred.We have analyzed the trace files of 5th and 6th for instrument ih-1000 (b)(6).There was no malfunction with the instrument; the pipetting steps were performed as expected, with the required washing between steps.No error event occurred during the pipetting batch, including the samples "(b)(6)".Likely the issue was caused by carry-over from the well (anti-d) to the next well (anti-b).We have analyzed the trace files of 5th and 6th for instrument ih-1000 5100042.There was no malfunction with the instrument; the pipetting steps were performed as expected, with the required washing between steps.No error event occurred during the pipetting batch, including the samples "(b)(6)".Likely the issue was caused by carry-over from the well (anti-d) to the next well (anti-b).Remarks and recommendations: as mentioned in the case description, "the customer removed the abo cards from the instrument and did see some reagent splashes, specifically in the anti-d wells." it is very important to advise the customer that using cards under these conditions may lead to unexpected/false positive results due to carryover.We recommend to the customer: to perform a visual inspection upon delivery.If the gel cards seem to be shaken during transport, this can be reported by escalating an operational case.Closely monitor the storage conditions.Inspect the product visually before using/ loading the instrument.Cards that present splashes of supernatant must be centrifuged before use, as recommended in the box insert.Don't use cards if splashes remain after centrifugation.Clean the gel card piercer on the instrument to avoid potential contamination on other gel cards.Adhere to the ifu/um instructions and follow lab best practices closely.

• 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: 24244754
• Report Number: 9610824-2026-00001
• Device Sequence Number: 8326945
• Product Code: QHR
• UDI-Device Identifier: 07611969964529
• UDI-Public: (01)07611969964529(17)261227(10)9535010
• 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
• Report Date (Section B): 02/03/2026

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: 9535010
• 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: 01/06/2026
• Initial Report FDA Received Date: 02/03/2026
• 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)
• Patient Sex: Unknown