Axis-Shield Diagnostics, Ltd.: Medical Device Recall in 2015 - (Recall #: Z-1946-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 20, 2015

Date Posted: July 8, 2015

Recall Number: Z-1946-2015

Event ID: 70992

Reason for Recall:

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

Status: Terminated

Product Quantity: 52 kits + 75 kits Beckman Coulter Brand OUS

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated