Alfa Wassermann, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1529-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 5, 2014

Date Posted: May 7, 2014

Recall Number: Z-1529-2014

Event ID: 67897

Reason for Recall:

Extremely low absorbance readings.

Status: Terminated

Product Quantity: 731 Kits

Code Information:

ACE¿ ALT Reagent (Product reorder number SA1046 Lot F3604)

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated