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Terminated

Dimension Free Thyroxine (FT4L) Flex reagent cartridge

FDA Recall Z-1669-2018 · Posted 2018-05-04

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeCEC
Date Initiated2018-01-02
Date Terminated2023-02-10

Reason for Recall

The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere.

Firm Action

Siemens Healthcare Diagnostics issued a recall in March 2017 for products with incorrect units for biotin in the Instructions for Use. After further investigation, recalling firm determined that more Siemens products also had missing or incorrect information in the IFUs for which two recalls were initiated, and Amended Corrections and Removals Reports were submitted to the FDA

Root Cause

Error in labeling

Distribution Pattern

Nationwide and Canada, Mexico, and Thailand

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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