FDA-Device2014-05-07Class II
Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitative determination of ALT in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office labs.
Alfa Wassermann, Inc.
Hazard
Extremely low absorbance readings.
Sold states
US Nationwide Distribution
Affected count
731 Kits
Manufactured in
4 Henderson Dr, West Caldwell, NJ, United States
Products
Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitative determination of ALT in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office labs.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1529-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief