Device product
VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged in a box with multiple slides. The lot and expiration codes are found on the side of the package. Product Usage: Intended use: For in vitro diagnostic use only. VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Z-2211-2012
Product summary
- Event
- Event 62612
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13338 sale units
- Official record key
device-enforcement:Z-2211-2012
Official wording
Reason: Ortho Clinical Diagnostics revised the VITROS Chemistry Products DGXN Slides Instructions for Use (IFU) and removed heparin plasma as a recommended specimen type for VITROS DGXN Slides
Code information: Lots from coating 0204, 0205, 0206. A Coating (CTG) is a unique identifier within the Lot Number of some of OCDs products
Distribution pattern: Worldwide Distribution - US (nationwide)
Derived failure modes
-
Unknown
Ortho Clinical Diagnostics revised the VITROS Chemistry Products DGXN Slides Instructions for Use (IFU) and removed heparin plasma as a recommended specimen type for VITROS DGXN Slides