Recall Z-1686-2018 ยท CDD Radioassay, Vitamin B12
Siemens Healthcare Diagnostics, Inc.
IMMULITE /IMMULITE 1000 Vitamin B12
| Date | May 4, 2018 (initiated Jan 2, 2018) |
| Status | Terminated |
| Reason | 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 | Error in labeling |
| Action | 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 |
| Distribution | Nationwide and Canada, Mexico, and Thailand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971177 | IMMULITE VITAMIN B12 (LKVB1,LKVB5) Diagnostic Products Corp., May 16, 1997 |