Recall Z-0614-2016
Siemens Healthcare Diagnostics Inc · initiated November 11, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus CS analyzer Catalog Number: CCCRP SMN:10445066
Codes / lots: Lot Number: 425229002
Reason for recall
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
FDA-determined cause: Labeling design
Action taken
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.
Details
- Recall number
- Z-0614-2016
- Initiated
- November 11, 2015
- Posted by FDA
- January 7, 2016
- Terminated
- September 23, 2016
- Product code
- NQD – Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
- Quantity
- 78
- 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.
- Recalling firm
- Siemens Healthcare Diagnostics Inc, Norwood, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0609-2016 Class II | Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac…Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | 11/11/2015Terminated |
| Z-0610-2016 Class II | Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative…Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | 11/11/2015Terminated |
| Z-0611-2016 Class II | Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in vitro diagnosticStratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | 11/11/2015Terminated |
| Z-0612-2016 Class II | Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative…Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | 11/11/2015Terminated |
| Z-0613-2016 Class II | Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB…Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | 11/11/2015Terminated |
| Z-0615-2016 Class II | Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for…Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | 11/11/2015Terminated |
| Z-0616-2016 Class II | Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be used for…Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | 11/11/2015Terminated |
| Z-0617-2016 Class II | Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for…Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | 11/11/2015Terminated |
| Z-0618-2016 Class II | Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnosticStratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | 11/11/2015Terminated |
| Z-0619-2016 Class II | Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in…Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | 11/11/2015Terminated |