FDA Device recall Z-1675-2018
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc 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-1675-2018 |
| 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 ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc
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 | Anti HBc, Anti HBc (IMMULITE 2000/IMMULITE 2000 XPi L2KHC2 (D)) Lot codes: Anti HBcM # 579 580 581 D579 D580 D581 ***Added 9/11/20*** D602 |
|---|
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-1675-2018%22
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