FDA Device recall Z-0616-2016
Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus CS analyze…
- FDA Device
- Class II
- terminated
- Published 2016-01-13
On 2016-01-13 the FDA classified a Class II recall of Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus CS analyze… 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-0616-2016 |
| 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 CCRP CalPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus CS analyzer Catalog Number: CCCRP-C SMN:10445067
Reason
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
Identifiers
| code_info | Lot Numbers: 625229002 |
|---|
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-0616-2016%22
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