Z-1529-2014 Class II Terminated
FDA device recall Z-1529-2014 was initiated by Alfa Wassermann, Inc. on March 5, 2014 and is designated Class II. Reason for recall: Extremely low absorbance readings. The recall status is terminated (terminated August 13, 2015). Affected quantity: 731 Kits.
Recall Details
- Product Type
- Devices
- Report Date
- May 7, 2014
- Initiation Date
- March 5, 2014
- Termination Date
- August 13, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 731 Kits
Product Description
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.
Reason for Recall
Extremely low absorbance readings.
Distribution Pattern
US Nationwide Distribution
Code Information
ACE¿ ALT Reagent (Product reorder number SA1046 Lot F3604)