Z-1468-2012

VITROS® 3600 Immunodiagnostic System

Name: Z-1468-2012 VITROS® 3600 Immunodiagnostic System
Creator: Ortho-Clinical Diagnostics
Published: 2012-03-15
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2012-03-15 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS® 3600 Immunodiagnostic System Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of... on 2012-03-15. The reason FDA records is "Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1468-2012
Status: Terminated
Initiated: 2012-03-15
Posted: 2012-04-26
Terminated: 2017-09-20
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS® 3600 Immunodiagnostic System Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Ortho Clinical Diagnostics (OCD) sent an Important Product Correction Notification letter dated March 15, 2012 via FedEx overnight courier to all affected customers. Foreign affiliates were informed by email on 15 March 2012 of the issue and instructed to notify their consignees of the issue and actions. The letter identified the affected products, problem and actions to be taken. The letter instructed customers to: 1) Consider performing the backup procedure more frequently to help prevent the loss of data on your system; 2) Contact OCD Customer Technical Service representatives if a hard drive failure occurs on your system; A Field Engineer will be dispatched to replace the hard drive on your system; 3) Complete and return the Confirmation of Receipt form upon receipt of this notification; and 4) Post this notification by each VITROS System in your facility or with the user documentation. For questions, refer to the Questions and Answers section. For additional questions, contact Customer Technical Services at 1-800-421-3311.
Quantity in commerce: 173
Distribution: Worldwide Distribution
Product codes and lots: Serial number range: 36000467 - 36000639

Product code JJE

K083173Class IIVitros Immunodiagnostic Products Tsh Reagent Pack and Calibrators, Vitros 3600 Immunodiagnostic SystemOrtho-Clinical Diagnostics / cleared 2008-12-22

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 2026-09-06. View this recall on fda.gov (opens on fda.gov)