| Class 2 Device Recall Acute Care BHCG TestPak | |
Date Initiated by Firm | November 11, 2015 |
Date Posted | January 07, 2016 |
Recall Status1 |
Terminated 3 on September 23, 2016 |
Recall Number | Z-0615-2016 |
Recall Event ID |
72570 |
510(K)Number | K060548 |
Product Classification |
System, test, human chorionic gonadotropin - Product Code DHA
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Product | Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus CS Acute Care hCG method
Catalog Number: CBHCG
SMN:10445060 |
Code Information |
Lot Numbers: 445146002, 445201002, 445243002 |
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 | 590 |
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 = DHA
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