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 (plase also see report 9610824-2025-00001) 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.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
Implant removed due to surgical consideration within 36 hours.

• 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: 21272506
• Report Number: 9610824-2025-00002
• Device Sequence Number: 11714927
• Product Code: QHR
• UDI-Device Identifier: 07611969951550
• UDI-Public: (01)07611969951550(17)250901(10)9337010-01
• 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: 09/01/2025
• Device Catalogue Number: 808068100
• Device Lot Number: 9407040-01
• 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: 01/02/2025
• 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): No
• 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 9407040-01.; SERACLONE ANTI-S, LOT 9407040-01.
• Patient Sex: Unknown