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U.S. Department of Health and Human Services

Class 2 Device Recall Acute Care MYO TestPak

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  Class 2 Device Recall Acute Care MYO TestPak see related information
Date Initiated by Firm November 11, 2015
Date Posted January 07, 2016
Recall Status1 Terminated 3 on September 23, 2016
Recall Number Z-0612-2016
Recall Event ID 72570
510(K)Number K051650  
Product Classification Myoglobin, antigen, antiserum, control - Product Code DDR
Product Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma
Catalog Number: CMYO
SMN:10445079
Code Information Lot Numbers: 515146002, 515201002, 515285002
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Inc
2 Edgewater Dr
Norwood MA 02062-4637
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 608
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
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.
510(K) Database 510(K)s with Product Code = DDR and Original Applicant = DADE BEHRING, INC.
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