ALINITY I CMV IGG REAGENT KIT
Received Apr 28, 2026 · Event occurred Apr 14, 2026
Report 3008344661-2026-00068 · MDR key 25020164
Device
Generic name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P42-22
Lot number
83053FZ00
Product problems
- False Positive Result
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P42 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P42-24/-33, AND 510K K220949. 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.
Description of Event or Problem
THE CUSTOMER OBSERVED POSITIVE ALINITY I CMV IGG RESULTS. ON (B)(6) 2026, SID (B)(6) (FEMALE) GENERATED ALINITY I CMV IGG REACTIVE OF 36.7AU/ML, BUT REPEATED NEGATIVE OF 0.3 AU/ML. THE PATIENT HISTORY IS KNOWN TO BE NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.