ELECSYS HTLV-I/II
Received May 29, 2026 · Event occurred Mar 29, 2026
Report 1823260-2026-02126 · MDR key 25333412
Device
Generic name
Human T-cell Lymphotrophic Virus 1 & 2 (htlv1 & Htlv2) Antibody Ivd, Kit
Manufacturer
Roche DiagnosticsCatalog number
09015272162
Lot number
ASKU
Product problems
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE ELECSYS SYPHILIS RESULT WAS OBTAINED ON A COBAS E 801 ANALYTICAL UNIT WITH SERIAL NUMBER (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HTLV-I/II AND ELECSYS SYPHILIS RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. THE ELECSYS HTLV-I/II RESULT WAS REACTIVE. ON (B)(6) 2026, THE (WESTERN BLOT METHOD) CONFIRMATORY HTLV TEST RESULT WAS "CONFIRMED INDETERMINATE". THE ELECSYS SYPHILIS RESULT WAS REACTIVE ON (B)(6) 2026, THE (CAPTIA-G METHOD) CONFIRMATORY SYPHILIS TEST RESULT WAS "CONFIRMED NON-REACTIVE". THE SAMPLE WAS REPEATED BECAUSE OF THE INITIALLY REACTIVE RESULTS. THIS MEDWATCH WILL APPLY TO THE ELECSYS HTLV-I/II ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS SYPHILIS ASSAY.