Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 qua — recall Z-1946-2015

U.S. FDA — Device Enforcement · United Kingdom · 2015-03-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1946-2015
Date of alert: 2015-03-20
Country / jurisdiction: United Kingdom
Risk level: Class II
Risk type: recall
Brand: Axis-Shield Diagnostics, Ltd.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 802899574

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

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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