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

Recall Z-0712-2024 — QMS Tacrolimus Calibrators, Product code 10015573

U.S. FDA — Device Enforcement · United States · 2023-11-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0712-2024
Date of alert
2023-11-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ortho-Clinical Diagnostics, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
74859619
Reported risk: Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry date: May 11, 2024, due to improper storage that is expected to degrade the quality of the calibrator and render it unsuitable for use. Use of the affected lot may results in erroneous calibration results, causing delay in 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.

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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.