Alfa Wassermann
4 Henderson Dr, West Caldwell, NJ, US
Registered product codes
37 product codes
Recent MDR events
1 on file
Recalls
5 on file
- TerminatedApr 30, 2014
Extremely low absorbance readings.
View FDA record ↗ - TerminatedApr 30, 2014
Extremely low absorbance readings.
View FDA record ↗ - TerminatedJan 28, 2013
Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.
View FDA record ↗ - TerminatedDec 17, 2008
Internal studies observed occasional unexpected outlier results in whole blood samples tested for Hemoglobin A1c using the EZA1c reagent on the ACE or ACE Alera clinical chemistry systems.
View FDA record ↗ - TerminatedMar 23, 2006
Inaccurate test results. The magnesium values for the A31/A41 Gemcal Serum calibrator gave control results that were biased approx. 20% high.
View FDA record ↗
Compliance history
Matched by FEI 1000122044.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.