Device Recall VITROS Chemistry Products PHYT Slides 의 리콜

Recall

69094

Class 2

Z-0007-2015

2014-08-20

2014-10-02

Terminated

United States

2017-04-11

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129618

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.

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.