MalfunctionKZB

BD KIESTRA¿ UCA POWERED BY BD SYNAPSYS¿ INFORMATICS SOLUTION

Received Apr 14, 2026 · Event occurred Mar 16, 2026

Report 3010141591-2026-00003 · MDR key 24877565

Device

Generic name

Calculator/data Processing Module

Manufacturer

Bd Kiestra Lab Automation

Catalog number

444902

Product problems

False Positive Result

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

H4. DEVICE MANUFACTURE DATE: UNKNOWN. 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 BD KIESTRA¿ UCA POWERED BY BD SYNAPSYS¿ INFORMATICS SOLUTION, THERE WERE AN UNSPECIFIED NUMBER OF FALSE POSITIVE RESULTS. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.