BD VERITOR¿ PLUS ANALYZER
Received May 1, 2026 · Event occurred Apr 2, 2026
Report 1119779-2026-00740 · MDR key 25059104
Device
Generic name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Manufacturer
Becton, Dickinson & Co. (sparks)Catalog number
256066
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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 ASSAY IS AS FOLLOWS: G4. PMA/510(K)#: EUA(B)(4). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED WHILE USING THE BD VERITOR¿ PLUS ANALYZER, A NEGATIVE FLU B RESULT FOR ONE (1) PATIENT SAMPLE WAS OBTAINED. HOWEVER, THE USER QUESTIONED THE RESULT AS THE PATIENT WAS SYMPTOMATIC AND A LINE WAS VISUALLY OBSERVED AT THE FLU B MARK. THE SAME TEST CARTIDGE WAS RE-INSERTED AND A "RESULT INVALID" ERROR APPEARED ON THE VERITOR ANALYZER. THERE WAS NO REPORT OF CONFIRMATORY TESTING PERFORMED. THE RESULT WAS VISUALLY INTERPRETED AND REPORTED AS FLU B POSITIVE. THE PATIENT WAS TREATED ACCORDINGLY AND NO HEALTH IMPACT OR CONSEQUENCES WERE REPORTED. IT SHOULD BE NOTED THE ACTIONS OF VISUAL INTERPRETATION AND REINSERTING A USED TEST CARTRIDGE ARE CONSIDERED OFF-LABEL USE OF THE PRODUCT.