| Class 2 Device Recall Dimension(R) EXL LOCI Cardiac Troponin I Calibrator (RC621) | |
Date Initiated by Firm | August 31, 2011 |
Date Posted | October 12, 2011 |
Recall Status1 |
Terminated 3 on May 20, 2013 |
Recall Number | Z-0038-2012 |
Recall Event ID |
59888 |
510(K)Number | K081683 |
Product Classification |
Immunoassay method, troponin subunit - Product Code JJE
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Product | Dimension(R) EXL LOCI Cardiac Troponin I Calibrator (RC621)
The LOCI Cardiac TNI Calibrator is an in vitro diagnostic product for the calibration on Cardiac Troponin I method on the Dimension(R) EXL (TM) Integrated chemistry system with LOCI(R) module. |
Code Information |
Lot Number 1AD045 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 500 GBC Drive, Mailstop 514 PO BOX 6101 Newark DE 19714-6101
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For Additional Information Contact | Robert J. King 302-631-0516 |
Manufacturer Reason for Recall | Internal testing has confirmed that recovery of levels 2 and 3 of LOCl Cardiac Troponin I Calibrator is lower than expected bottle value. Following calibration with LOCl Cardiac Troponin I Calibrator, lot 1AD045 an upward shift in patient and QC results may be observed. |
FDA Determined Cause 2 | Other |
Action | Siemens sent an Urgent Field Safety Notice dated August 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and discard any remaining inventory. Replacement orders would be processed and sent free of charge. Customers were also instructed to complete the attached FIELD CORRECTION EFFECTIVENESS CHECK form and fax it to (302) 631- 8457.
Customers were instructed to forward the Safety Notice to anyone to whom they may have distributed the affected product.
For any technical questions customers were to contact the Siemens Solutions Center at 800-441-9250. |
Quantity in Commerce | 998 |
Distribution | Worldwide Distribution - USA (nationwide) including AL, AK, AZ, AR, CA, CO, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY and the countries of GUAM, Austria, Canada, China, Czech Republic, Egypt, France, Germany, Italy, Poland, Portugal, Puerto Rico, Spain and Switzerland. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JJE
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