ALINITY I CMV IGG REAGENT KIT
Received Jul 14, 2025 · Event occurred Jul 4, 2025
Report 3008344661-2025-00096 · MDR key 22494116
Device
Generic name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P42-22
Lot number
72312FZ00
Product problems
- False Positive Result
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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 07P42-22THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P42-24/-33, WITH 510K NUMBER K220949.
Description of Event or Problem
THE CUSTOMER OBSERVED A FALSE REACTIVE ALINITY I CMV IGG RESULT GENERATED ON THE ALINITY I PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) INITIAL RESULT 10.2 AU/ML (REACTIVE), REPEATED ON PRIMARY TUBE AND ON ALIQUOT MADE BEFORE THE FIRST TEST WAS PERFORMED: BOTH RESULTS WERE NON-REACTIVE 0.3 AU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER: A FALSE REACTIVE ALINITY I CMV IGG RESULT WAS REPORTED FOR ANOTHER SAMPLE. SID (B)(6) INITIAL RESULT CMV IGG 172.4 U/ML (REACTIVE), REPEATED <6 U/ML; RERUN PERFORMED ON PRIMARY TUBE AND ALIQUOT AND BOTH RESULTS WERE <6 U/ML. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. REVIEW OF TRACKING AND TRENDING DATA FOR THE ALINITY I CMV IGG ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINTS. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR THE REAGENT LOT. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. CLINICAL SPECIFICITY TESTING WAS PERFORMED USING AN IN-HOUSE RETAIN KIT OF ALINITY I CMV IGG REAGENT LOT 72312FZ00. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I CMV IGG REAGENT WAS IDENTIFIED.
Description of Event or Problem
THE CUSTOMER OBSERVED A FALSE REACTIVE ALINITY I CMV IGG RESULT GENERATED ON THE ALINITY I PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) INITIAL RESULT 10.2 AU/ML (REACTIVE), REPEATED ON PRIMARY TUBE AND ON ALIQUOT MADE BEFORE THE FIRST TEST WAS PERFORMED: BOTH RESULTS WERE NON-REACTIVE 0.3 AU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.