Recall Z-0818-2014
Siemens Healthcare Diagnostics, Inc. · initiated December 5, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements are used as an aid in the management of heart, liver, and kidney transplant patients.
Codes / lots: lots 12300BB, exp. 10-26-2013; 12318BB, exp. 11-13-2013; and 13011BB, exp. 1-11-2014.
Reason for recall
Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges.
FDA-determined cause: Nonconforming Material/Component
Action taken
Siegmens sent an Urgent Medical Device Recall lletter dated December 2013 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use and discard any remaining inventory of the affected product. Customers were also instructed to complete the attached form and fax it to 302-631-8467. Customers were asked to retain the letter with their laboratory records, and forward the letter to any who have received the affected product. Customers with questions were instructed to contact Siemens Customer Care Center - Technical Solutions or their local Siemens technical support representative. For questions regarding this recall call 800-441-9250.
Details
- Recall number
- Z-0818-2014
- Initiated
- December 5, 2013
- Posted by FDA
- January 23, 2014
- Terminated
- August 27, 2014
- Product code
- MKW – Cyclosporine
- Quantity
- 1586
- Distribution
- Worldwide Distribution - USA (nationwide) and Canada.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Newark, DE