Recalls / —
—#141554
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
- FDA product code
- NQD — Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
- Device class
- Class 2
- Medical specialty
- Immunology
- 510(k) numbers
- K062924
- Affected lot / code info
- Lot Number: 425229002
Why it was recalled
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
Root cause (FDA determination)
Labeling design
Action the firm took
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.
Recalling firm
- Firm
- Siemens Healthcare Diagnostics Inc
- Address
- 2 Edgewater Dr, Norwood, Massachusetts 02062-4637
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2015-11-11
- Posted by FDA
- 2016-01-07
- Terminated
- 2016-09-23
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #141554. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.