ALINITY I CMV IGG REAGENT KIT
Received Jun 9, 2026 · Event occurred Jun 1, 2026
Report 3008344661-2026-00086 · MDR key 25443880
Device
Generic name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P42-32
Lot number
78311FZ00
Product problems
- False Positive Result
Patient
32 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I CMV IGG RESULTS ON A 32YRS OLD PREGNANT FEMALE PATIENT. THE RESULTS PROVIDED WERE: SID: (B)(6), INITIAL=149.5 AU/ML (> OR = 6.0 AU/ML=REACTIVE) /REPEATED ON VIDAS=NEGATIVE (NO ACTUAL RESULTS PROVIDED). REPEATED ON ALINITY (B=0.2 AU/ML (< 6.0 AU/ML=NONREACTIVE). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P42-22/32, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P42-24/-33, WITH 510K/PMA/BLA NUMBER K220949.