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

Recall Z-0957-2013 — Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.

U.S. FDA — Device Enforcement · United States · 2012-11-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0957-2013
Date of alert
2012-11-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Healthcare Diagnostics, Inc.
Product category
device
Product type
Devices
Reported risk: Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot FA3085. Quality Control (QC) materials have not exhibited low recovery of the same magnitude. Internal method regression testing versus LC/MS has shown an average 25% low bias compared to LC/MS across the assay range. Individual patients, particularly samples with lower TACR values
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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