MAUDE Adverse Event Report: ALBA BIOSCIENCE LIMITED (LTD.) ALBACYTE® GROUP A2 REAGENT RED BLOOD CELLS; REAGENT RED BLOOD CELLS, PRODUCT CODE: QHT

Model Number	Z406U
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is concluded yet.As soon as will be completed follow medwatch will be submitted.
Event or Problem Description
Ten end users reported false positive results with albacyte® group a2 reagent red blood cells, product z406u lot v284011 expiry 30jun25 against albalect¿ anti-a1, product z241u lot v273091 expiry 01aug26.Associated trender records: (b)(4).
Additional Manufacturer Narrative
Follow up report submitted as the investigation has been completed.Our investigation has determined albacyte® group a2 reagent red blood cells, product z406u lot v284011 and albalec anti-a1, product z241u lot v273091 to be fit for purpose with the expected results recorded when following the recommended ifu test method.Therefore, this complaint is deemed unconfirmed.
Event or Problem Description
Follow up report.

• Brand Name: ALBACYTE® GROUP A2 REAGENT RED BLOOD CELLS
• Common Device Name: REAGENT RED BLOOD CELLS, PRODUCT CODE: QHT
• Manufacturer (Section D): ALBA BIOSCIENCE LIMITED (LTD.); 5 james hamilton way; milton bridge; penicuik, uk EH26 0BF; UK EH26 0BF
• Manufacturer (Section G): ALBA BIOSCIENCE LIMITED (LTD.); 5 james hamilton way; milton bridge; penicuik, uk EH26 0BF; UK EH26 0BF
• Manufacturer Contact: samuele serfilippi ; 5 james hamilton way; milton bridge; penicuik, uk EH26 -0BF ; UK EH26 0BF
• MDR Report Key: 22296068
• Report Number: 3011683976-2025-00005
• Device Sequence Number: 8819715
• Product Code: QHT
• UDI-Device Identifier: 05060242471131
• UDI-Public: 05060242471131
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: 125337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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
• Device Expiration Date: 06/30/2025
• Device Model Number: Z406U
• Device Lot Number: V284011
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 06/25/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown