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 Chemi
Check against the official notice below — it lists the full affected range.
Ortho-Clinical Diagnostics has recalled VITROS Chemistry Products PHYT Slides (REF/CATALOG 829 8671) due to the potential for biased results when processing citrate plasma specimen samples. The current Instructions for Use and Assay Summary Chart list serum, heparin plasma, and citrate plasma as acceptable specimen types, but the firm identified that citrate plasma samples may produce unreliable results. The product has been distributed worldwide, including throughout the United States, Puerto Rico, and 20 other countries.
A total of 4,680 units were distributed in the US and 1,286 units were distributed to foreign countries. The recall affects expired, current, and future product generations with unique identifier number 10758750004690. The recall notice does not specify what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 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. Quantity: US; 4680; Foreign: 1286 Lot/code info: Unique Identifier Number ( UDI) 10758750004690; This issue affects expired, current (in date) and future product GENs.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.