Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of cycl
FDA device recall Z-0818-2014 · posted 2014-01-23 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MKW
- Quantity affected
- 1586
- Distribution
- Worldwide Distribution - USA (nationwide) and Canada.
- Date initiated
- 2013-12-05
- Date posted
- 2014-01-23
- Date terminated
- 2014-08-27
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE (K062236) | Dade Behring, Inc. | 2006-08-21 |