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

Recall Z-2623-2023 — VITROS XT Chemistry Products TBIL-ALKP Slides

U.S. FDA — Device Enforcement · United States · 2023-08-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2623-2023
Date of alert
2023-08-05
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)
10758750031801
Reported risk: Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.
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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