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Terminated

VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. 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.

FDA Recall Z-0967-2015 · Posted 2015-01-14

Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeJJE
Date Initiated2014-11-19
Date Terminated2018-05-21
Product Quantity658 total: USA - 144, Foreign - 514

Reason for Recall

Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration.

Firm Action

On 11/19/2014, IMPORTANT PRODUCT CORRECTION NOTIFICATION letter (Ref. CL2014-296, dated 11/19/2014) was sent via FedEx overnight courier or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to the US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and advise them of the required actions. Immediately install the most recent ADD using the All Assay Data option. If any of your calibrations are expired, the system will post PZB-005 condition codes. Perform calibrations prior to using those reagents. As expected, calibrations that will expire within one hour will also be flagged. Continue to install the most recent ADD at least once each week using the All Assay Data load option so that the system properly flags expired calibrations. --- Foreign affiliates were informed by e-mail on 11/19/2014 of the issue and instructed to notify their consignees of the issue and required actions.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K083173VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEMOrtho-Clinical Diagnostics · 2008-12-22K081543VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEMOrtho-Clinical Diagnostics, Inc. · 2008-10-23K063144VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEMOrtho-Clinical Diagnostics, Inc. · 2006-11-13K031924VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1Ortho-Clinical Diagnostics · 2003-08-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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