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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Chemistry Products DT Calibrator Kit

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 Class 2 Recall
VITROS Chemistry Products DT Calibrator Kit
see related information
Date Posted January 27, 2012
Recall Status1 Open
Recall Number Z-0917-2012
Recall Event ID 60799
Premarket Notification
510(K) Number
K091861 
Product Classification Calibrator, Multi-Analyte Mixture - Product Code JIX
Product 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, CHOL, CK, Cl-, CO2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.
Code Information Kit Lot 37 (exp. 3/31/12) and Kit Lot 38 (exp. 3/31/13)
Recalling Firm/
Manufacturer
Ortho-Clinical Diagnostics
100 Indigo Creek Drive
Rochester, New York 14626
Consumer Instructions No consumer action necessary
For Additional Information Contact Ms. Carol Montandon
908-218-8190
Manufacturer 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 &
FDA Determined
Cause 2
DESIGN: 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 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.
Quantity in Commerce 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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JIX and Original Applicant = ORTHO-CLINICAL DIAGNOSTICS, INC.
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