Home / Recalls / Axis-Shield Diagnostics, Ltd. / Z-1946-2015

Z-1946-2015 Class II Terminated

Recalled by Axis-Shield Diagnostics, Ltd. — Dundee

Recall Details

Product Type: Devices
Report Date: July 8, 2015
Initiation Date: March 20, 2015
Termination Date: October 27, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 52 kits + 75 kits Beckman Coulter Brand OUS

Product Description

Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum.

Reason for Recall

Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of: KY, WA, CA, and PA and the country of Germany.

Code Information

Part Number/Lot Number: FHBC100/802899574; FHRWR100/802899249; FHRWR1000/802899248; FHRWR200/802899989; FHRWR200/802899250; FHRWCN1/802900104