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

Recall Z-1471-2017 — VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per sales unit) and REF/Catalog Number/Product Code 8318925 (60 slide format / 300 slides per sales unit), Unique Identifier Nos. 10758750009466 and 10758750004720, RX ONLY, IVD --Orth

U.S. FDA — Device Enforcement · United States · 2017-02-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1471-2017
Date of alert
2017-02-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ortho-Clinical Diagnostics
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10758750009466
Reported risk: Intermittent imprecision in results generated using two specific lots of VITROS Li 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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