Z-1699-2012

VITROS 5600 Integrated System Software Version 1.6 & Below

Name: Z-1699-2012 VITROS 5600 Integrated System Software Version 1.6 & Below
Creator: Ortho-Clinical Diagnostics
Published: 2012-04-26
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2012-04-26 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS 5600 Integrated System Software Version 1.6 & Below Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement... on 2012-04-26. The reason FDA records is "Ortho Clinical Diagnostics is recalling VITROS 5600 Integrated System Software Version 1.6 and below because of an anomaly that may inadvertently add a surfactant to a CurveTip position". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1699-2012
Status: Terminated
Initiated: 2012-04-26
Posted: 2012-06-01
Terminated: 2018-07-05
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS 5600 Integrated System Software Version 1.6 & Below Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Ortho Clinical Diagnostics is recalling VITROS 5600 Integrated System Software Version 1.6 and below because of an anomaly that may inadvertently add a surfactant to a CurveTip position.
Root cause tag: software
FDA root cause: Software design
Action: Ortho Clinical Diagnostics (OCD) sent an Urgent Product Correction Notification letter dated April 26, 2012, via FedEx overnight courier to US consignees with VITROS 5600 Systems. The letter identified the affected product, problem and actions to be taken. Foreign affiliates were informed by email on April 26, 2012 of the issue and instructed to notify their consignees of the issue and actions. OCD recommend customers to group all DAT assays into a single run as described in the letter, until the next Software Version 2.0 is installed on their VITROS 5600 System. Customers were instructed to complete and return the Confirmation of Receipt form. For questions contact Customer Technical Services at 1-800-421-3311
Quantity in commerce: 1357 units
Distribution: Worldwide Distribution - US (nationwide)
Product codes and lots: Product code: 6802413; Serial numbers: 56000118 - 56001498

Product code JJE

K081543Class IIVitros Immunodiagnostic Products Tsh Reagent Pack and Calibrators, Vitros 5600 Integrated SystemOrtho-Clinical Diagnostics, Inc. / cleared 2008-10-23

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)