Recall Z-2283-2012 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Siemens Healthcare Diagnostics, Inc.
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
| Date | Aug 28, 2012 (initiated Jun 7, 2012) |
| Status | Terminated |
| 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. |
| 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063356 | STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK Dade Behring, Inc., Mar 23, 2007 |