MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMNH BLOOD GROUPING REAGENT ANTI-K, 5ML; SERACLONE ANTI-K (KEL1)

Catalog Number	808090100
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our combined initial and final report on this incident.
Event or Problem Description
The customer reported weak and apparently false negative test results with seraclone anti-k with donor units when incubated at room temperature for 5 minutes.When tests were repeated with washed red cells and the incubation time increased to 10 minutes at room temperature, the reactions were 1 positive.Qc was passed with heterozygous k positive cells.The customer did not provide patient samples that had caused the weak or negative reactions nor a product sample of seraclone anti-k for investigational testing.Therefore, our quality control laboratory tested their retention samples per the ifu.The potency (titer more or equal 1:512) met batch release acceptance criteria; positive specificity was confirmed (with k+k+ cells); negative specificity was confirmed with k-k+ cells, all negative.The reported issue could not be reproduced internally.The manufacturing and qc record reviews showed no deviations that could have impacted the quality of the product.The customer's qc passed, and a 3+ reaction was obtained with a positive heterozygous k panel cell, supporting that there is no product qc involvement.Donor phenotype profiles were not available from the customer; the ifu indicates that heterozygous k+k+ cells may show weaker reactions.Customer testing conditions included aged and variable donor units (from multiple blood centers and with different anticoagulants; one unit within approximately two weeks of expiry) and centrifugation settings were not aligned with the ifu (customer: 3000 rpm for 15 s used vs.Ifu recommendation for 20 s), which may contribute to weak reactions.Conclusion: the reagent is performing as intended.The most probable contributors are pre-analytical variables (sample age and/or improper reagent storage) and testing parameters deviating from the ifu.There is no evidence of a lot related quality defect.

• Brand Name: BLOOD GROUPING REAGENT ANTI-K, 5ML
• Common Device Name: SERACLONE ANTI-K (KEL1)
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMNH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 24363224
• Report Number: 9610824-2026-00008
• Device Sequence Number: 10201168
• Product Code: QHR
• UDI-Device Identifier: 07611969951574
• UDI-Public: (01)07611969951574(17)260822(10)9510040-01
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: 125230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2026

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 Expiration Date: 08/22/2026
• Device Catalogue Number: 808090100
• Device Lot Number: 9510040-01
• 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: 01/22/2026
• Initial Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (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