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

Recall Z-1642-2022 — T-Cell Xtend REF TTK.610 US

U.S. FDA — Device Enforcement · United Kingdom · 2022-07-07 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1642-2022
Date of alert
2022-07-07
Country / jurisdiction
United Kingdom
Risk level
Class II
Risk type
recall
Brand
OXFORD IMMUNOTEC LTD
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
15051716000022
Reported risk: Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time.
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.

Related

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.