IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Gastrin
Published May 16, 2018 · Recall initiated: January 2, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- Nationwide and Canada, Mexico, and Thailand
- Lot
- Gastrin, Gastrin (IMMULITE/IMMULITE 1000, LKGA1), (IMMULITE 2000/IMMULITE 2000 XPi, LKGA2) Lot codes: 251 252 253 254 255
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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