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

Recall Z-1670-2021 — Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e

U.S. FDA — Device Enforcement · United States · 2021-04-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1670-2021
Date of alert
2021-04-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Beckman Coulter Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
15099590742713
Reported risk: specimens collected in transport media may result is false negative results when stored in certain conditions.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.