Recall Z-1615-2013— Ortho-Clinical Diagnostics
Class III · Terminated
Class III FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2013-05-09, terminated 2015-06-12. FDA's recall record names no specific 510(k) clearance for this event. Product: VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.. Reason: While performing interval testing Ortho Clinical Diagnostics (OCD) determined that an excess amount of surfactant was unintentionally added to VITROS Chemistry Products CRP Slides during the manufacturing process..
- Recalling firm
- Ortho-Clinical Diagnostics
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2013-05-09
- Terminated
- 2015-06-12
- Firm location
- Rochester, NY, United States
Product description
VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration 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
While performing interval testing Ortho Clinical Diagnostics (OCD) determined that an excess amount of surfactant was unintentionally added to VITROS Chemistry Products CRP Slides during the manufacturing process.
Data sourced from openFDA. This site is unofficial and independent of the FDA.