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

Recall Z-1436-2014 — Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.

U.S. FDA — Device Enforcement · United States · 2013-02-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1436-2014
Date of alert
2013-02-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Clinical Diagnostic Solutions
Product category
device
Product type
Devices
Reported risk: Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.
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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