Z-1678-2018 Class II Terminated
FDA device recall Z-1678-2018 was initiated by Siemens Healthcare Diagnostics, Inc. on Jan 2, 2018 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Feb 10, 2023).
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- Jan 2, 2018
- Termination Date
- Feb 10, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
IMMULITE ¿ /IMMULITE ¿ 1000 CEA
Reason for Recall
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.
Distribution Pattern
Nationwide and Canada, Mexico, and Thailand
Code Information
CEA, CEA (IMMULITE/IMMULITE 1000, LKCE1), (IMMULITE 2000/IMMULITE 2000 XPi, LKCE2, LKCE6) Lot codes: 0355 0356 0357
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1678-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026