BD VERITOR¿ PLUS ANALYZER
Received Jun 15, 2026 · Event occurred May 18, 2026
Report 1119779-2026-00947 · MDR key 25501111
Device
Generic name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Manufacturer
Becton, Dickinson & Co. (sparks)Catalog number
256066
Product problems
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED WHILE USING THE BD VERITOR¿ PLUS ANALYZER, THE CUSTOMER WAS RECEIVING A POSITIVE RESULT FOR EVERY SAMPLE TESTED. THE TESTING INCLUDED AN UNSPECIFIED NUMBER OF PATIENT SAMPLES, QUALITY CONTROL, AND A BLANK SAMPLE WHICH EITHER RESULTED AS POSITIVE FOR STREP A OR POSITIVE FOR COVID AND FLU A+B. UPON RECEIVING A REPLACEMENT ANALYZER, QUALITY CONTROL SAMPLES PASSED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
B3. DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE REQUESTED 510K INFORMATION FOR THE INVOLVED VERITOR ASSAYS ARE AS FOLLOWS: G4. PMA/510(K)#: K122718 AND EUA203152. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.