FDA Device recall Z-1341-2022
Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to…
- FDA Device
- Class II
- terminated
- Published 2022-07-13
On 2022-07-13 the FDA classified a Class II recall of Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to… 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-1341-2022 |
| 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 CTNI-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): 10444905/RF421C
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: 00842768013836GA232320221119 Lot Number: GA2323 Exp. Date: 11-19-2022 Recall Extended 9/21/22: UDI: 008427680…UDI-DI: 00842768013836GA232320221119 Lot Number: GA2323 Exp. Date: 11-19-2022 Recall Extended 9/21/22: UDI: 00842768013836BA308820230329 Lot Number: BA3088 Exp. Date: 2023-03-29 |
|---|
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-1341-2022%22
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