Recall Z-1529-2014— Alfa Wassermann, Inc.

Name: FDA recall Z-1529-2014
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: K131351. Product: 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: 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

K131351 — ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENTAlfa Wassermann Diagnostic Technologies, LLC·cleared 2013-08-15

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 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.

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