Recalls / —
—#124628
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.
- FDA product code
- MKW — Cyclosporine
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K062236
- Affected lot / code info
- lots 12300BB, exp. 10-26-2013; 12318BB, exp. 11-13-2013; and 13011BB, exp. 1-11-2014.
Why it was recalled
Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Address
- 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466
Distribution
- Distribution pattern
- Worldwide Distribution - USA (nationwide) and Canada.
Timeline
- Recall initiated
- 2013-12-05
- Posted by FDA
- 2014-01-23
- Terminated
- 2014-08-27
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #124628. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.