ALINITY S HTLV I/II REAGENT KIT
Received Apr 28, 2026 · Event occurred Apr 7, 2026
Report 1415939-2026-00012 · MDR key 25020764
Device
Generic name
Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donatio
Manufacturer
Abbott LaboratoriesCatalog number
06P07-61
Lot number
80048MM00
Product problems
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HTLV I/II RESULTS FOR MULTIPLE DONOR SAMPLES THAT WERE NEGATIVE FOR THE NAT TESTING. THE FOLLOWING INFORMATION WAS PROVIDED. THE CUTOFF IS 1.00 S/CO. SID (B)(6); INITIAL RESULT = 3.44 S/CO REACTIVE, REPEAT TESTING = REACTIVE, REPEAT- REACTIVE, RETENTION TUBE = NON-REACTIVE, NAT= NEGATIVE. SID (B)(6); INITIAL RESULT = 2.10 S/CO REACTIVE, REPEAT TESTING = REACTIVE, REPEAT- REACTIVE, RETENTION TUBE = NON-REACTIVE, NAT= NEGATIVE. SID (B)(6) ; INITIAL RESULT = 3.15 S/CO REACTIVE, REPEAT TESTING = REACTIVE, REPEAT- REACTIVE, RETENTION TUBE = NON-REACTIVE, NAT= NEGATIVE. SID (B)(6); INITIAL RESULT = 2.65 S/CO REACTIVE, REPEAT TESTING = REACTIVE, REPEAT- REACTIVE, RETENTION TUBE = NON-REACTIVE, NAT= NEGATIVE. SID (B)(6) ; INITIAL RESULT = 2.38 S/CO REACTIVE, REPEAT TESTING = REACTIVE, REPEAT- REACTIVE, RETENTION TUBE = NON-REACTIVE, NAT= NEGATIVE. SID (B)(6): INITIAL RESULT = 2.71 S/CO REACTIVE, REPEAT TESTING = REACTIVE, REPEAT- REACTIVE, RETENTION TUBE = NON-REACTIVE, NAT= NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.