Recall Z-0917-2012 ยท JIX Calibrator, Multi-Analyte Mixture
Ortho-Clinical Diagnostics
VITROS Chemistry Products DT Calibrator Kit, REF/Catalog No. 195 7927, IVD --- Common/Usual Name: VITROS DT Calibrator Kit -- Ortho-Clinical Diagnostics, Inc. Rochester, NY -- Ortho-Clinical Diagnostics High Wycombe, UK VITROS Chemistry Products DT Calibrator Kit is an in vitro diagnostic specially formulated for use as calibrators for ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHO
| Date | Jan 27, 2012 (initiated Oct 13, 2011) |
| Status | Terminated |
| Reason | 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 & |
| Root cause | Component design/selection |
| Action | 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 u |
| Quantity | 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, Singapore, and Venezuela |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K934071 | KODAK EKTACHEM DT SLIDES (URCR) Eastman Kodak Company, Mar 21, 1994 |