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

Recall Z-0895-2018 — Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400

U.S. FDA — Device Enforcement · United States · 2017-08-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0895-2018
Date of alert
2017-08-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Instrumentation Laboratory Co.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
0020301400
Reported risk: Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample results.
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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