ARCHITECT ANTI-HCV
Received Jul 20, 2026 · Event occurred Jul 1, 2026
Report 3002809144-2026-00192 · MDR key 25883121
Device
Generic name
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Manufacturer
Abbott GmbhCatalog number
06C37-28
Lot number
83135BE00
Product problems
- False Negative Result
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED FALSE NONREACTIVE ARCHITECT ANTI-HCV II RESULTS GENERATED ON THE ARCHITECT I1000SR ANALYZER FOR A DIALYSIS PATIENT. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: < 1.00 S/CO NONREACTIVE):ON 01JUL2026, SID 2617410: ANTI-HCV II RESULT = 0.21 S/CO (NONREACTIVE)ON 02JUL2026, REPEAT TESTING WITH THE SAME SAMPLE FROM WHICH THE PCR TEST WAS PERFORMED = 0.12 S/CO (NONREACTIVE).PCR RESULT = POSITIVE .THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
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 06C37, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 1L79 WITH 510K/PMA/BLA NUMBER P050042.