Recall Z-1614-2013— Ortho-Clinical Diagnostics
Class III · Terminated
Class III FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2013-05-09, terminated 2015-06-12. It names one FDA 510(k) clearance: K083680. Product: VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products K+ Slides quantitatively measure potassium (K+) concentration in serum, plasma, and urine 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 a surfactant was unintentionally added to VITROS Chemistry Products K+ 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
510(k) clearances named in this recall
1 on FDA's recordK-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 K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products K+ Slides quantitatively measure potassium (K+) concentration in serum, plasma, and urine 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 a surfactant was unintentionally added to VITROS Chemistry Products K+ Slides during the manufacturing process.
Data sourced from openFDA. This site is unofficial and independent of the FDA.