FDA Device recall Z-1682-2018
IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125)
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125) by Siemens Healthcare Diagnostics, citing 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 Siro….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1682-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-02 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125)
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.
Identifiers
| code_info | OM-MA (CA125), OM-MA (CA125) (IMMULITE/IMMULITE 1000, LKOP1), (IMMULITE 2000/IMMULITE 2000 XPi, LKOP2) Lot codes: CA125 (OM-MA) 0211 0212 0213 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1682-2018%22
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