Siemens Healthcare Diagnostics, Inc. Recall: IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin
Siemens Healthcare Diagnostics, Inc. Recall: IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Siemens Healthcare Diagnostics, Inc.; Product: IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin; Reason for recall: Concentrations for the level of biotin that does not i
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
|---|---|
| Product | IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Nationwide and Canada, Mexico, and Thailand |
| Recall initiated | 20180102 |
| Recall number | Z-1680-2018 |
| Category | device |
| State | NY |
| Country | United States |
$29/mo
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