ALINITY S HIV AG/AB COMBO REAGENT KIT
Received Apr 27, 2026 · Event occurred Apr 13, 2026
Report 3002809144-2026-00105 · MDR key 25002047
Device
Generic name
Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donatio
Manufacturer
Abbott GmbhCatalog number
06P01-55
Lot number
78155BE00
Product problems
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S HIV AG/AB COMBO RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID(B)(6). (B)(6) 2026 ALINITY S HIV AG/AB RESULTS 2.10 / 2.17 / 0.07 S/CO (B)(6) 2026 COBAS E801 RESULTS 0.250 / 0.253 / 0.273 COI. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 06P01-55 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6P01-60 / 61, WITH 510K NUMBER BL125679. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.