Device Recall VITROS Immunodiagnostic Products CA 199 Reagent Pack and CA 199 Calibrators 의 리콜

Recall

68890

Class 2

Z-2183-2014

2014-07-16

2014-08-11

Terminated

United States

2017-03-06

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128956

Customers may receive positively biased results when using vitros¿ immunodiagnostic products ca 19-9 total reagent packs, lot 1320 and vitros¿ ca 19-9 calibrators, lot 1320 on the vitros eci/eciq immunodiagnostic systems, the vitros 3600 immunodiagnostic system and the vitros 5600 integrated system. there is an unexpected observed change in ca 19-9 calibrators, lot 1320 calibrator values.

Ortho Clinical Diagnostics sent an Urgent Product Correction Notification July 2014 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to Immediately discontinue using and discard Lots 1320 of VITROS CA 19-9 Calibrators and Reagent Packs. Review previously reported VITROS 25-OH Vitamin D Total results using Lot 1320. Review quality control results used to verify calibration events. Results lower than the target mean may indicate potentially biased assay results. Discuss any concerns regarding previously reported results with the Laboratory Medical Director or with the requesting physician. Complete and return the attached Confirmation of Receipt form. OCD will: credit their account for all VITROS¿ CA 19-9 Calibrators and Reagent Packs that were discarded or ship repalcment product uspon request. Customers were instructed to forward the information in this notification if they have distributed this product outside of their facility. Customers with questions were instructed to contact their Customer Technical Service representative or contact the Customer Technical Service representative at 1-800-421-3311.