Z-0917-2012

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

Name: Z-0917-2012 VITROS Chemistry Products DT Calibrator Kit, REF/Catalog No. 195 7927, IVD --- Common/Usual Name: VITROS DT...
Creator: Ortho-Clinical Diagnostics
Published: 2011-10-13
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2011-10-13 / Terminated / root cause: design

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products DT Calibrator Kit, REF/Catalog No. 195 7927, IVD --- Common/Usual Name: VITROS DT Calibrator Kit -- Ortho-Clinical Diagnostics, Inc... on 2011-10-13. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0917-2012
Status: Terminated
Initiated: 2011-10-13
Posted: 2012-01-27
Terminated: 2016-02-12
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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.
Product code: JIX Calibrator, Multi-Analyte Mixture
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 &
Root cause tag: design
FDA 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 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
Product codes and lots: Kit Lot 37 (exp. 3/31/12) and Kit Lot 38 (exp. 3/31/13)

Product code JIX

K934071Class IIKodak Ektachem Dt Slides (Urcr)Eastman Kodak Company / cleared 1994-03-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)