FDA Device recall Z-0619-2016
Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the Acute Care CKMB TestPak Catalog…
- FDA Device
- Class II
- terminated
- Published 2016-01-13
On 2016-01-13 the FDA classified a Class II recall of Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the Acute Care CKMB TestPak Catalog… 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-0619-2016 |
| 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 CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the Acute Care CKMB TestPak Catalog Number: CCKMB-D SMN: 10445070
Reason
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
Identifiers
| code_info | Lot Numbers: 845173002 |
|---|
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-0619-2016%22
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