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Terminated

VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.

FDA Recall Z-0077-2015 · Posted 2014-10-16

Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeJJE
Date Initiated2014-09-08
Date Terminated2018-05-21
Product QuantityUSA: 97; Foreign: 232

Reason for Recall

Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Internal testing confirmed that when using calibrator barcode labels supplied with VITROS Chemistry Products Calibrator Kits 1, 2, 3, 4, 6, or 9, an unexpected assay calibration may occur if assay targets are unassigned (i.e., hidden).

Firm Action

On 9/08/14, URGENT PRODUCT CORRECTION NOTIFICATION Letter (CL2014-232, dated 9/8/14) and Confirmation of Receipt Form were sent via FedEx overnight courier or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (OCD Direct, Drop-Ship and US Federal Government only) to inform them of the issue and advise them of the required actions. Foreign affiliates were informed of the issue via e-mail on 9/8/14 and instructed to notify their consignees of the issue and the required actions.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution-USA (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.

K063144VITROS 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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