Dimension Vista Thyroid Stimulating Hormone (TSH) Flex… recallZ-1673-2018 · Siemens Healthcare Diagnostics, Inc. · initiated Jan 2, 2018
Class II Terminated All recalls posted in May 2018
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Error in labeling
What the company is doing
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
Recall details
- Recall number
- Z-1673-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jan 2, 2018
- Posted by the FDA
- May 4, 2018
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product code
- JLW
- FDA submissions
- K140859
- Distribution
- Nationwide and Canada, Mexico, and Thailand
Product description
Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
Code information (models, lots, serial numbers)
TSH, radioimmunoassay, thyroid stimulating hormone, RF612, SMN# 10464524 Lot codes: 16277BD 16322BB 17005BB 17023AC 17069AA 17093BB 17122AA 17150AA 17193BA 17215AC 17268AA
Other devices under the same FDA submission
2 devices cleared under K140859 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Dimension Vista® Flex® reagent cartridge TSH 10445104Siemens Healthcare Diagnostics Inc. · RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE19 reports
- Dimension Vista® Flex® reagent cartridge FT4 10445103Siemens Healthcare Diagnostics Inc. · RADIOIMMUNOASSAY, FREE THYROXINE13 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 79505).
- Z-1670-2018 · TerminatedDimension Sirolimus (SIRO) Flex reagent cartridge
- Z-1671-2018 · TerminatedDimension Vista Cardiac Troponin I (CTNI) Flex reagent cartridge
- Z-1672-2018 · TerminatedDimension Vista Mass Creatine Kinase (MMB) Flex reagent cartridge
- Z-1674-2018 · TerminatedIMMULITE 2000/IMMULITE 2000 XPi 3g Allergy specific IgE Universal Kit
- Z-1677-2018 · TerminatedIMMULITE /IMMULITE 1000 BR-MA (CA15-3)
- Z-1679-2018 · TerminatedIMMULITE 2000/IMMULITE 2000 XPi CEA
- Z-1685-2018 · TerminatedIMMULITE 2000/IMMULITE 2000 XPi TG
- Z-1686-2018 · TerminatedIMMULITE /IMMULITE 1000 Vitamin B12
- Z-1687-2018 · TerminatedADVIA Centaur Cyclosporine
- Z-1689-2018 · TerminatedADVIA Centaur Folate (FOL)
- Z-1691-2018 · TerminatedIMMULITE 2000/IMMULITE 2000 XPi BR-MA (CA15-3)
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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