VITROS Chemistry Products DT Calibrator Kit, REF/Catalog No. 195 7927, IVD --- Common/Usual Name: VITROS DT Calibrator K

FDA device recall Z-0917-2012 · posted 2012-01-27 · Terminated

Recall details

Recalling firm

Ortho-Clinical Diagnostics

Reason for recall

Ortho Clinical Diagnostics (OCD) was notified by customers of negatively biased quality control results obtained while using VITROS Chemistry Products NBIL DT Slides, GEN 72. OCD performed an internal investigation and confirmed that negatively biased NBIL results could occur for quality control, proficiency and patient samples. As a result, VITROS Chemistry Products DT Calibrator Kit Lots 37 &

Action taken

Ortho Clinical Diagnostics (Johnson & Johnson Company) sent an Important Product Correction Notification letter dated October 13, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to recalibrate and instructing them to recalibrate VITROS Chemistry Products NBIL DT Slides, GEN 72 with updated DT calibrator values for the NBIL assay provided on CDM 0164. J&J Foreign affiliate consignees were notified by e-mail on October 13, 2011, informing them of the issue and of the availability of the updated CDM (0164). Consignees were instructed to complete and return the attached Confirmation of Receipt form upon receipt of the notification even if they do not use VITROS NBIL Slides in their facility. If the affected product was distributed outside the consignees facility they were instructed to forward the notification letter to affected customers. For any questions regarding this recall call 1-800-421-3311.

Root cause

Component design/selection

Status

Terminated

Product code

JIX

Quantity affected

12,750 units (Lot 37: domestic - 1403, foreign - 3488; Lot 38: domestic - 50, foreign - 30)

Distribution

Worldwide Distribution - USA (nationwide) Puerto Rico and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Si

Date initiated

2011-10-13

Date posted

2012-01-27

Date terminated

2016-02-12

Location

Rochester, NY

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