—#96799

Product

Stratus(R) CS Acute Care Troponin I TestPak, Troponin I Assay The Stratus(R) CS Acute CareTM Troponin I method (CTNI) is an in vitro diagnostic test for the measurement of cardiac Troponin I in heparinized plasma. Cardiac Troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI). Cardiac Troponin I can also be used as an aid in the risk stratification of patients with acute coronary syndromes (ACS) with respect to their relative risk of mortality.

FDA product code: MMI — Immunoassay Method, Troponin Subunit
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K051650
Affected lot / code info: Lot #s: 230347002, 230340002, 230333002, 230326002, 230319002, 230312002, 230305002, 230298002, 230284002, 230277002, 230270002, 230263002, 230256002, 230250002, 230242002, 230236002, 230227002, 230214002, 230207002, 230201002 and 230200002.

Why it was recalled

Low frequency of non-repeatable falsely elevated CTNI results without an associated error message.

Root cause (FDA determination)

Other

Action the firm took

The firm, SIEMENS, sent an "Urgent Field Safety Notice" letter dated December 2010 to all Stratus(R) CS Instrument customers. The letter described the product, problem and actions to be taken. The customers were instructed to repeat testing of samples with CTNI results above 0.07 ng/mL; discuss content of this letter with their laboratory director regarding the need to review test results reported from CTNI TestPak lots 230200002 or greater; complete and return the FIELD CORRECTION EFFECTIVENESS CHECK form via fax to Technical Solutions Center at 302-631-8467, and forward this notification to anyone to whom they may have distributed this product. If you have any questions, please contact the Siemens Technical Solutions Center at 800-405-6473.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101

Distribution

Distribution pattern: Worldwide distribution: AL, AK, AZ, AR, CA, CO, DC, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.Product was distributed to foreign accounts in Algeria, Armenia, Australia, Austria, Bahrain, Bangladesh,Belgium, Bosnia & Herzegovina, Canada, Canary Islands, Czech Republic, Cyprus, Croatia, Denmark, Finland, France, Germany, Great Britain, Greece, Guadeloupe, Indonesia, India, Israel, Ireland, Italy, Japan, Libya, Malaysia, Morocco, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Arab Emirates.

Timeline

Recall initiated: 2010-12-23
Posted by FDA: 2011-03-18
Terminated: 2013-03-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #96799. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.