MAUDE Adverse Event Report: ALBA BIOSCIENCE LIMITED (LTD.) ALBACYTE GROUP A2 REAGENT RED BLOOD CELLS

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	02/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medwatch submitted becasue according to the health hazard evaluation the risk has been classified as high, meaning the event could led to a serious injury.No serious injury or health impact has been reported.Investigation is not completed yet.As soon as it will be completed a follow up report will be submitted.Alba biosicence reference number of this file is (b)(4).
Event or Problem Description
The end user reports false positive results with albacyte group a2 reagent red blood cells, product z406u lot v280597.The end user reports 2+ positive results when tested against albalect anti-a1, product z241u lot v273091.A total of four end users reported false positive with the product albacyte group a2 reagent red blood cells, product z406u lot v280597.

• Brand Name: ALBACYTE GROUP A2 REAGENT RED BLOOD CELLS
• Common Device Name: REAGENT RED BLOOD CELLS
• 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: 21650606
• Report Number: 3011683976-2025-00002
• Device Sequence Number: 7499234
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2025

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: 03/10/2025
• Device Model Number: Z406U
• Device Lot Number: V280597
• 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: 02/19/2025
• Initial Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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