FDA · Medical device recall

VITROS 3600 Immunodiagnostic System… and 2 more products

Jan. 21, 2015 Class II

Date: Jan. 21, 2015
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Terminated
Filed by: Ortho-Clinical Diagnostics
Reason: 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.
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.

3 products in this recall

VITROS 3600 Immunodiagnostic System…

Product: 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.
Quantity: 658 total: USA - 144, Foreign - 514
Codes and lots: Software Version 3.1 & Below; Serial Numbers J36000101 - J36000834 (the serial numbers are sequential; J Numbers are analogous to serial numbers)
Recall started: Nov. 19, 2014
Device type: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Root cause (FDA): Software design
What the company told customers: 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.
Recall number: Z-0967-2015

VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)…

Product: VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD --- Ortho Clinical Diagnostics. 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).
Quantity: 339 Total: USA - 102, Foreign - 237
Codes and lots: Software Version 3.1 & Below; Serial Numbers J46000108 - J46000492 (the serial numbers are sequential; J Numbers are analogous to serial numbers)
Recall started: Nov. 19, 2014
Device type: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Root cause (FDA): Software design
What the company told customers: 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.
Recall number: Z-0968-2015

VITROS 5600 Integrated System…

Product: VITROS 5600 Integrated System, Catalog Number 6802413, 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 Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
Quantity: 1830 Total: USA - 877, Foreign - 953
Codes and lots: Software Version 3.1 & Below; Serial Numbers J56000110 - J56002044 (the serial numbers are sequential; J Numbers are analogous to serial numbers)
Recall started: Nov. 19, 2014
Device type: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Root cause (FDA): Software design
What the company told customers: 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.
Recall number: Z-0969-2015

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0967-2015, Z-0968-2015, Z-0969-2015. The agency record governs; check it and the company before acting.

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