Siemens Healthcare recalls Dimension FT4L reagent cartridges with incorrect biotin interference levels. This may affect lab test accuracy. Contact for remedy details.
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.
Siemens Healthcare is recalling Dimension FT4L reagent cartridges because the instructions incorrectly list biotin interference levels. This could lead to inaccurate thyroid hormone tests if used in labs.
The instructions for use incorrectly state the biotin level that doesn't interfere with tests. This could cause inaccurate thyroid hormone measurements if the cartridges are used in labs.
Lab technicians and healthcare facilities using Siemens Dimension FT4L reagent cartridges with specific lot numbers. Those handling the cartridges are most at risk.
Check for lot codes: EA7276, EC7304, EC7333, EA7346, EB8010, EA8037, EA8065, EB8:8086, EB8108, EA8130, EA8156, EA8179, EA8205, EA8233, FD8254. The product is a Dimension FT4L Flex reagent cartridge.
Identify if your cartridge has any of the listed lot codes: EA7276, EC7304, EC7333, EA7346, EB8010, EA8037, EA8065, EB8086, EB8108, EA8130, EA8156, EA8179, EA8205, EA8233, FD8254.
The instructions incorrectly state the biotin level that does not interfere with tests, which could lead to inaccurate thyroid hormone measurements.
Check for lot codes: EA7276, EC7304, EC7333, EA7346, EB8010, EA8037, EA8065, EB8086, EB8108, EA8130, EA8156, EA8179, EA8205, EA8233, FD8254.
The recall record does not specify a remedy, so contact Siemens Healthcare for further instructions.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1669-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1669-2018 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
