Z-2283-2012Class III

Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The...

Name: Z-2283-2012 Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2012-06-07
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-06-07 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a 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 Calibrator (DDMR... on 2012-06-07. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2283-2012
Classification: Class III
Status: Terminated
Initiated: 2012-06-07
Posted: 2012-08-28
Terminated: 2014-01-16
Recalling firm: Siemens Healthcare Diagnostics Inc.
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
Product code: DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: SIEMENS sent an Urgent Field Safety Notice dated June 7, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter included a response form to be faxed to the recalling firm at 302-631-8467 by the consignee. If customers experienced calibration failures, they were instructed to contact the Siemens Technical Solutions Center at 800-405-6473 for assistance. Customers were also asked to forward the notification to anyone to whom they may have distributed the affected product. For questions regarding this recall call 302-631-6311.
Quantity in commerce: 786 cartons
Distribution: Nationwide Distribution - USA including AK, AL, AR, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, WA, WI, WV, and WY.
Product codes and lots: DDMR CalPak lots 502058002, exp 2012/11/23 and 501318002, exp 2012/08/10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2283-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2283-2012	Class III	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-28

Product code DAP

K063356Class IIStratus Cs Acute Care D-Dimer Testpak, Dilpak, CalpakDade Behring, Inc. / cleared 2007-03-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)