FDA Device recall Z-0609-2016
Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma Catalog Number: CC…
- FDA Device
- Class II
- terminated
- Published 2016-01-13
On 2016-01-13 the FDA classified a Class II recall of Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma Catalog Number: CC… by Siemens Healthcare Diagnostics, citing stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0609-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-11 |
| Published | 2016-01-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma Catalog Number: CCTNI SMN: 10445071
Reason
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
Identifiers
| code_info | Lot Numbers: 235151002, 235159002, 235166002, 235173002, 235208002 235215002, 235222002, 235229002, 235236002, 235243…Lot Numbers: 235151002, 235159002, 235166002, 235173002, 235208002 235215002, 235222002, 235229002, 235236002, 235243002 235250002, 235257002, 235278002, 235285002 |
|---|
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-0609-2016%22
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