| Class 2 Device Recall Acute Care CKMB TestPak | |
Date Initiated by Firm | November 11, 2015 |
Date Posted | January 07, 2016 |
Recall Status1 |
Terminated 3 on September 23, 2016 |
Recall Number | Z-0613-2016 |
Recall Event ID |
72570 |
510(K)Number | K051650 |
Product Classification |
Fluorometric method, cpk or isoenzymes - Product Code JHX
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Product | Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine NPhosphostransferase, E. C. No. 2.7 .3.2) in heparinized plasma
Catalog Number: CCKMB
SMN:10445068 |
Code Information |
Lot Numbers: 245138002, 245152002, 245215002, 245262002 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics Inc 2 Edgewater Dr Norwood MA 02062-4637
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For Additional Information Contact | 781-269-3000 |
Manufacturer Reason for Recall | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
FDA Determined Cause 2 | Labeling design |
Action | Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on November 11, 2015 both in the United States and internationally for communication with affected customers. This notice informs customers of the issue and provides mitigation instructions. Customers with questions were advised to contact their Siemens Customer Care Center or their local Siemens technical support representative. For questions regarding call 781-269-3000. |
Quantity in Commerce | 1051 |
Distribution | Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom. |
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 = JHX
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