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Terminated

VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Unique Device Identifier Number 10758750001644, Software Version 2.8 and below, IVD. Product Usage: The VITROS 5,1 FS 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-0643-2016 · Posted 2016-01-13

Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeJJE
Date Initiated2015-11-03
Date Terminated2018-05-30
Product QuantityVITROS 5,1: Domestic - 932, Foreign - 1245; 5,1 Refurbished: Domestic - 63; Foreign - 153

Reason for Recall

Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems continue to operate and process results without notification to the User, possibly producing erroneous results.

Firm Action

Ortho-Clinical Diagnostics sent an Urgent Product Correction Letters (Ref. CL2015-211, dated November 3, 2015) via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address) to all customers who received the affected devices (VITROS 3600 and 5600 Systems). The notification identified the affected products, problem and actions to be taken. Foreign affiliates were informed via e-mail on 11/03/2015 of the issue and instructed to notify their consignees of the issue and required actions. Ortho-Clinical Diagnostics sent an Urgent Product Correction Letters (Ref. CL2015-221, dated November 11, 2015) via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address) to all customers who received the affected devices (VITROS 5,1 FS and 4600 users). The notification identified the affected products, problem and actions to be taken. Foreign affiliates were informed via e-mail on 11/11/2015 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 and the countries of Puerto Rico, and foreign distribution to: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Israel, Italy, Japan, Kenya, Mexico, Panama, Philippines, Poland, Romania, Russia, Singapore, Spain, Taiwan, Turkey, 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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