—#129618

Product

VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. 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.

FDA product code: DIP — Enzyme Immunoassay, Diphenylhydantoin
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K941142
Affected lot / code info: Lot Number 2613-0150-4913, exp. 15-Nov-2014

Why it was recalled

Ortho Clinical Diagnostics identified a potential for biased results to be generated when using VITROS PHYT Slides, Lot 2613-0150-4913. Some positively biased results were identified during testing of a different VITROS PHYT Slide lot; the affected slides were not released for distribution. Since Lot 2613-0150-4913 was manufactured in the same event, there is the potential for slides from this lot to also be affected.

Root cause (FDA determination)

Software Manufacturing/Software Deployment

Action the firm took

On 8/20/14, an URGENT PRODUCT CORRECTION NOTIFICATION Letter (CL2014-222, dated 8/20/14) was sent via FedEx overnight courier and/or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and advise them to discontinue use of the affected lot(s) and to inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. One foreign affiliate was notified on 8/20/14. One distributor was notified on 8/20/14. The customers were advised to: - Immediately discontinue using and discard VITROS Chemistry Products PHYT slide Lot 2613-0150-4913. Review VITROS PHYT results obtained using Lot 2613-0150-4913 and discuss any concerns they may have regarding previously reported results with their Laboratory Medical Director or with the requesting physician. Complete the attached Confirmation of Receipt form no later than 8/28/14. Forward the information in this notification if they have distributed this product outside of their facility facility.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 513 Technology Blvd, Rochester, New York 14626-3601

Distribution

Distribution pattern: Distributed USA (nationwide) and in Singapore.

Timeline

Recall initiated: 2014-08-20
Posted by FDA: 2014-10-02
Terminated: 2017-04-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129618. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.