Z-0273-2018 Class II Terminated
FDA device recall Z-0273-2018 was initiated by Ortho-Clinical Diagnostics on June 12, 2017 and is designated Class II. Reason for recall: The firm identified the potential for biased results to be generated when processing VITROS PHYT Slide product with citrate plasma specimen samples. The current Instructions for Use (IFU) and Assay S… The recall status is terminated (terminated August 11, 2020). Affected quantity: US; 4680; Foreign: 1286.
Recall Details
- Product Type
- Devices
- Report Date
- January 3, 2018
- Initiation Date
- June 12, 2017
- Termination Date
- August 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US; 4680; Foreign: 1286
Product Description
VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) 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
The firm identified the potential for biased results to be generated when processing VITROS PHYT Slide product with citrate plasma specimen samples. The current Instructions for Use (IFU) and Assay Summary Chart state serum, heparin plasma, and citrate plasma as acceptable specimen types for use with the PHYT assay.
Distribution Pattern
Worldwide Distribution - US Distribution including Puerto Rico and the following countries: Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, Russia and Venezuela.
Code Information
Unique Identifier Number ( UDI) 10758750004690; This issue affects expired, current (in date) and future product GENs.