MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT ANTI-JK(B); SERACLONE ANTI-JK(B)

Catalog Number	808184100
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
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 a false negative reaction of seraclone anti-jkb to our distributor in switzerland.The customer claims to have performed input control of the reagent in accordance with the instructions for use.The positive control, using test erythrocytes with heterozygous antigen expression (3% erythrocyte suspension biotestcell p3), showed a negative result.The procedure was repeated twice, and both times the positive control remained negative.For the control they used biotestcell-p3.The customer dd not provide a patient sample or a product sample of the allegedly defective lot of seraclone anti-jkb for investigational testing.Therefore, our quality control laboratory tested their retention sample according to the instructions for use.Testing sensitivity and titers: the reported lot demonstrated high sensitivity, with titers exceeding the minimum requirement of 1:8 on tested jk(a+b+) donor samples.The results were strong and consistent with expectations.The reference donors jk(a+b+) showed reactivity with titers of 1:64 and 1:32.Testing specificity: all jk(b+) red cells (reference samples and donor) reacted strongly positive.All jk(b-) cells reacted clearly negative, with no non-specific agglutination, confirming correct specificity and absence of any cross-reactivity.Further testing: positive and negative controls and reference samples (jk(a+b+), jk(a-b+), jk(a+b-)) were tested in comparison.No discrepancies were detected; all reactions and outcomes were as expected.Conclusion: the reported lot demonstrated the expected specificity and sensitivity, showed no discrepancies with reference materials, and was found to be fully compliant.No product related quality issue was detected.Customer testing procedure: we have not received detailed feedback from the customer regarding their exact testing protocol.They only confirmed that the test was performed according to the guidelines.Based on previous experience, deviations from the ifu such as incubation time, centrifugation speed and duration, diluent used, cell suspension concentration, or washing steps can often result in inconsistent results.We advised the customer to strictly follow the ifu instructions, including: preparing a proper 3-5% suspension of red blood cells, incubating test mixtures for 15-20 minutes at room temperature, centrifuging for 60 seconds at 800-1000 × g using calibrated instruments, reading results immediately after centrifugation to avoid misinterpretation.To ensure accurate interpretation of results, the customer is also advised to be aware of the test limitations and to note the difference between "cells ready for use" and "pre-washed cells suspended in nacl" when negative results occur, as these may indicate that residual preservatives, proteins, or cell-suspension media are reducing the reaction of the test.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.

• Brand Name: BLOOD GROUPING REAGENT ANTI-JK(B)
• Common Device Name: SERACLONE ANTI-JK(B)
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 22993044
• Report Number: 9610824-2025-00032
• Device Sequence Number: 18546586
• Product Code: QHR
• UDI-Device Identifier: 07611969951796
• UDI-Public: (01)07611969951796(17)260912(10)3504070-00
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: 125217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2025

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: 09/12/2026
• Device Catalogue Number: 808184100
• Device Lot Number: 3504070-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 09/08/2025
• 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: BIOTESTCELL-P3, LOT 3528011-00.
• Patient Sex: Unknown