FDA Device recall Z-1340-2022
Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma t…
- FDA Device
- Class II
- terminated
- Published 2022-07-13
On 2022-07-13 the FDA classified a Class II recall of Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma t… by Siemens Healthcare Diagnostics, citing positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to inappropriate intervent….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1340-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-05-18 |
| Published | 2022-07-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444896/RF521
Reason
Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to inappropriate intervention for myocardial infarction
Identifiers
| code_info | UDI-DI: 00842768013904EA231420221110 Lot Number: EA2314 Exp. Date: 11-10-2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1340-2022%22
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