Stratus(R) CS Acute Care Troponin I TestPak, Troponin I Assay The Stratus(R) CS Acute CareTM Troponin I method (CTNI) is
FDA device recall Z-1732-2011 · posted 2011-03-18 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- Low frequency of non-repeatable falsely elevated CTNI results without an associated error message.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MMI
- Quantity affected
- 11635
- Distribution
- 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,
- Date initiated
- 2010-12-23
- Date posted
- 2011-03-18
- Date terminated
- 2013-03-19
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK. (K051650) | Dade Behring, Inc. | 2005-09-08 |