MalfunctionMJH
BARTELS ELISA LEGIONELLA URINIARY ANTIGEN
Received Nov 10, 2021 · Event occurred Sep 27, 2021
Report 1318354-2021-00003 · MDR key 12787010
Device
Generic name
Legionella Urinary Antigen
Manufacturer
Trinity Biotech, UsaModel number
B1029-440Catalog number
B1029-440
Lot number
056
Product problems
- Contamination of Device Ingredient or Reagent
- Contamination of Device Ingredient or Reagent
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
LABORATORY USER INFORMED MANUFACTURER THAT THEIR NEW SHIPMENT OF LUA KITS B1029-440 LOT 056 WAS FOUND TO HAVE SOME SORT OF GEL/PRECIPITATE IN EVERY BOTTLE OF CONJUGATE.
Description of Event or Problem
LABORATORY USER INFORMED MANUFACTURER THAT THEIR NEW SHIPMENT OF LUA KITS B1029-440 LOT 056 WAS FOUND TO HAVE SOME SORT OF GEL/PRECIPITATE IN EVERY BOTTLE OF CONJUGATE.
Remedial action
- Recall
- Replace