Alfa Wassermann, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1530-2014)

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 AST Reagent. Product Usage: For quantitative determination of AST 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 laboratories.

Product Classification:

Class II

Date Initiated: March 5, 2014

Date Posted: May 7, 2014

Recall Number: Z-1530-2014

Event ID: 67897

Reason for Recall:

Extremely low absorbance readings.

Status: Terminated

Product Quantity: SA1047 lot F3609: 146; RX1047 lot F3610: 53

Code Information:

ACE¿ AST Reagent Product reorder numbers SA1047 (Lot F3609) and RX1047 (Lot F3610)

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated