Recall Z-0299-2014— Ortho-Clinical Diagnostics
Class II · Terminated
Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2013-06-12, terminated 2017-04-11. It names 2 FDA 510(k) clearances: K001679, K934413. Product: VITROS Chemistry Products AST Slides packaged as 300 slides/pack catalog number 8433815 VITROS AST Slides quantitatively measure aspartate aminotransferase (AST) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Reason: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues..
- Recalling firm
- Ortho-Clinical Diagnostics
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-06-12
- Terminated
- 2017-04-11
- Firm location
- Rochester, NY, United States
510(k) clearances named in this recall
2 on FDA's record- K001679 — VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3
- K934413 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ASPARATE AMIMOTRANSFERASE
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
VITROS Chemistry Products AST Slides packaged as 300 slides/pack catalog number 8433815 VITROS AST Slides quantitatively measure aspartate aminotransferase (AST) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System
Reason for recall
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
Data sourced from openFDA. This site is unofficial and independent of the FDA.