FDA Device recall Z-1671-2018
Dimension Vista¿ Cardiac Troponin I (CTNI) Flex¿ reagent cartridge
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of Dimension Vista¿ Cardiac Troponin I (CTNI) Flex¿ reagent cartridge 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-1671-2018 |
| 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
Dimension Vista¿ Cardiac Troponin I (CTNI) Flex¿ reagent cartridge
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 | CTNI, immunoassay method, troponin subunit, K6421, SMN# 10445098 Lot codes: 16336BA 16347BD 16363BC 17032AD 170…CTNI, immunoassay method, troponin subunit, K6421, SMN# 10445098 Lot codes: 16336BA 16347BD 16363BC 17032AD 17045BC 17054BD 17074BC 17093BD 17121BA 17145BE 17180BB 17193BD 17201BB 17223BA 17264BC |
|---|
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-1671-2018%22
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