MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMNH BLOOD GROUPING REAGENT ANTI-S, 2ML; SERACLONE ANTI-S (MNS4)

Catalog Number	808068100
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported false negative results with seraclone anti-s.The customer performed a lot-to-lot comparison (please also see report 9610824-2025-00002) between two lots of seraclone anti-s on (b)(6) 2024, using heterozygotes panel cells for their positive qc and the reaction strength was 3+ for all positive cells tested.These same cells were tested again on (b)(6) 2024 and showed weak 1+ reactions.Using a new panel received earlier in the day, the cell that was tested with both lots showed negative results.The customer announced to send in a product sample of the affected lots of seraclone-s.So far, the samples have not arrived on our premises.
Event or Problem Description
The customer reported that positive reactions with two different lots of seraclone anti-s were only weak positive in the test method immediate spin (see also report 9610824-2025-00002).The customer stated that controls and patient samples were affected.One patient sample even showed a false negative reaction.It was not clear which of the two lots yielded a false negative result, so we filed one report for each lot.The customer returned one vial of seraclone anti-s, lot 9407040-01 for investigational testing but did not send in the patient sample that had caused the false negative test result.Our quality control laboratory tested the product sample returned by the customer in parallel with their retension samples of both affected lots 9407040-01 and lot 9337010-01.The investigation showed the following results: the product sample provided by the customer reacted as strongly as the retention sample of lot 9407040-01.The retention sample of lot 9337010-01 reacted as strongly as lot 9407040-01.All positive samples reacted positively with both lots and the negative donor samples reacted negatively.Only three positive specificities could be tested with the material provided by the customer because the material was then depleted.We were unable to confirm the customer's claim.We assume that the weak positive or false negative result they obtained was related to the handling of their initial vial.
Additional Manufacturer Narrative
This is our final report on this incident.

• Brand Name: BLOOD GROUPING REAGENT ANTI-S, 2ML
• Common Device Name: SERACLONE ANTI-S (MNS4)
• 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: 21272598
• Report Number: 9610824-2025-00001
• Device Sequence Number: 3810508
• Product Code: QHR
• UDI-Device Identifier: 07611969951550
• UDI-Public: (01)07611969951550(17)260202(10)9407040-01
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: 125214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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: 02/02/2026
• Device Catalogue Number: 808068100
• Device Lot Number: 9407040-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2025
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SERACLONE ANTI-S, LOT 9337010-01; SERACLONE ANTI-S, LOT 9337010-01
• Patient Sex: Unknown