—#111478

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

FDA product code: DAP — Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K063356
Affected lot / code info: DDMR CalPak lots 502058002, exp 2012/11/23 and 501318002, exp 2012/08/10

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2012-06-07
Posted by FDA: 2012-08-28
Terminated: 2014-01-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111478. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.