FDA Device recall Z-2283-2012
Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The Stratus(R) CS Acute Care(TM) D-dimer…
- FDA Device
- Class III
- terminated
- Published 2012-09-05
On 2012-09-05 the FDA classified a Class III recall of Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The Stratus(R) CS Acute Care(TM) D-dimer… by Siemens Healthcare Diagnostics, citing siemens has confirmed that the Stratus(R) CS Acute Care(TM) D-Dimer CalPak calibrator lots 502058002 and 501318002 may exhibit SLOPE or CALCV error messages (instrument errors), w….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2283-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-06-07 |
| Published | 2012-09-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDMR CalPak), Catalog No. CDDMR-C is an in-vitro diagnostic product intended to be used for the calibration of the Stratus(R) CS Acute Care(TM) D-dimer )DDMR) method
Reason
Siemens has confirmed that the Stratus(R) CS Acute Care(TM) D-Dimer CalPak calibrator lots 502058002 and 501318002 may exhibit SLOPE or CALCV error messages (instrument errors), which indicate calibration failures.
Identifiers
| code_info | DDMR CalPak lots 502058002, exp 2012/11/23 and 501318002, exp 2012/08/10 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2283-2012%22
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