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MalfunctionKZJ

BD BBL¿ DRY ANAEROBIC INDICATOR STRIPS

Received Apr 15, 2026 · Event occurred Mar 25, 2026

Report 2647876-2026-00025 · MDR key 24887948

Device

Generic name

Device, Gas Generating

Catalog number

271051

Lot number

5329942

Product problems

  • Device Ingredient or Reagent Problem

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. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD BBL¿ DRY ANAEROBIC INDICATOR STRIPS, THE CUSTOMER NOTICED SOME OF THE INDICATOR STRIPS ARE NOT TURNING WHITE AFTER BEING PLACED IN THEIR LARGE GASPAK EZ CONTAINER, AND OTHERS TAKES LONGER FOR THEM TO TURN WHITE ON UNSPECIFIED NUMBER OF PATIENT SAMPLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.