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

Recall Z-2875-2020 — VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) concentration in serum and plasma, Product Code: 6844296

U.S. FDA — Device Enforcement · United States · 2020-07-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2875-2020
Date of alert
2020-07-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ortho-Clinical Diagnostics
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10758750031801
Reported risk: Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
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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