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

Recall Z-0441-2021 — Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499

U.S. FDA — Device Enforcement · United States · 2020-10-06 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0441-2021
Date of alert
2020-10-06
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Hardy Diagnostics
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00819398026499
Reported risk: Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling contains an expiration date of 2021-11-10 instead of the correct expiration date of 2020-11-10
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.

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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.