Recall Z-1530-2014— Alfa Wassermann, Inc.

Name: FDA recall Z-1530-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-05

Class II · Terminated

Class II FDA medical device recall by Alfa Wassermann, Inc., initiated 2014-03-05, terminated 2015-08-13. It names one FDA 510(k) clearance: K113382. Product: 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.. Reason: Extremely low absorbance readings..

Recalling firm: Alfa Wassermann, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-03-05
Terminated: 2015-08-13
Firm location: West Caldwell, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K113382 — ACE ALT REAGENTAlfa Wassermann·cleared 2012-07-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

Extremely low absorbance readings.

Data sourced from openFDA. This site is unofficial and independent of the FDA.