—#162509

Product

IMMULITE /IMMULITE 1000 CEA

FDA product code: DHX — System, Test, Carcinoembryonic Antigen
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K970877
Affected lot / code info: CEA, CEA (IMMULITE/IMMULITE 1000, LKCE1), (IMMULITE 2000/IMMULITE 2000 XPi, LKCE2, LKCE6) Lot codes: 0355 0356 0357

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.

Root cause (FDA determination)

Error in labeling

Action the firm took

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

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern: Nationwide and Canada, Mexico, and Thailand

Timeline

Recall initiated: 2018-01-02
Posted by FDA: 2018-05-04
Terminated: 2023-02-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162509. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.