Device product
Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa Wassermann B.V. Pompmolenlaan 24 3447 GK, Woerden The Netherlands Common name is water solution. Intended to dilute reagents and rinse the parts of a clinical chemistry instrument.
Z-0743-2013
Product summary
- Event
- Event 63866
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,104 kits
- Official record key
device-enforcement:Z-0743-2013
Official wording
Reason: Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.
Code information: Lot Number 155599
Distribution pattern: Worldwide Distribution - USA (nationwide) and the countries of Canada and Cayman Islands
Derived failure modes
-
Unknown
Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.