VITROS Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITROS CA 19-9 Reagent Packs are used o

FDA device recall Z-2183-2014 · posted 2014-08-11 · Terminated

Recall details

Recalling firm

ORTHO-CLINICAL DIAGNOSTICS

Reason for recall

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

NIG

Quantity affected

475

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to France and Japan

Date initiated

2014-07-16

Date posted

2014-08-11

Date terminated

2017-03-06

Location

Bridgend, United Kingdom