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.
Enforcement
- Recall Number
- Z-1614-2013
- Event ID
- 65247
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ortho-Clinical Diagnostics
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- July 3, 2013
- Initiation Date
- May 9, 2013
- Classification Date
- June 27, 2013
- Termination Date
- June 12, 2015
- Address
- 100 Indigo Creek Dr, Rochester, NY, 14626-5101, United States
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.
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.
GEN 4102, Coating 0884, Lot XXXX (exp. 06/01/2014) and GEN 4102, Coating 0885, Lot XXXX (exp. 06/01/2014 and 07/01/2014). The term GEN and Coating refer to specific segments of the reagent lot number.
Worldwide Disribution - USA Nationwide including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain and Venezuela.
Domestic: 236,364; Foreign: 8,339