CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report
Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge recalled
Siemens Healthcare Diagnostics is recalling Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge, distributed nationwide in the US. The recall was initiated on 2 Jan 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1669-2018
- FDA event ID
- 79505
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Jan 2018
- FDA classified
- 4 May 2018
- Reported
- 16 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 2 Jan 2018 | Recall initiated by company | |
| 4 May 2018 | Classified by FDA | +122 days |
| 16 May 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge
Where it was distributed
Nationwide and Canada, Mexico, and Thailand
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
FT4L, radioimmunoassay, free thyroxime, RF610, SMN# 10464523 Lot codes: EA7276 EC7304 EC7333 EA7346 EB8010 EA8037 EA8065 EB8086 EB8108 EA8130 EA8156 EA8179 EA8205 EA8233 FD8254
Where was it sold?
Nationwide and Canada, Mexico, and Thailand
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
23 other products · FDA event 79505This product is part of a recall event; the main page for the event is Immulite ¿ 2000/Immulite ¿ 2000 XPi Br-ma (CA15-3) recalled.
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