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

Recall Z-0743-2020 — Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.

U.S. FDA — Device Enforcement · United Kingdom · 2019-09-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0743-2020
Date of alert: 2019-09-16
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): 05055845400169

Reported risk: There is a potential performance issue as detected by an under-recovery of sample results during routine testing.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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.

Recall Z-0743-2020 — Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.

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