IMMULITE /IMMULITE 1000 Vitamin B12 recallZ-1686-2018 · 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
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
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-1686-2018
- 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
- CDD
- FDA submissions
- K971177
- Distribution
- Nationwide and Canada, Mexico, and Thailand
Product description
IMMULITE /IMMULITE 1000 Vitamin B12
Code information (models, lots, serial numbers)
Vitamin B12, Vitamin B12 (IMMULITE/IMMULITE 1000, LKVB1) Lot codes: 0338 0339 0340 0341
Other devices under the same FDA submission
1 device cleared under K971177 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- IMMULITE®/IMMULITE® 1000 Systems VB Vitamin B12 10380900Siemens Healthcare Diagnostics Products Ltd · RADIOASSAY, VITAMIN B121 report
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-1673-2018 · TerminatedDimension Vista Thyroid Stimulating Hormone (TSH) 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-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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