FDA · Medical device recall

VITROS® 3600 Immunodiagnostic System Product Usage: For use in the in… and 4 more products

April 26, 2012

Date posted by the FDA: April 26, 2012
Status: Terminated
Filed by: Ortho-Clinical Diagnostics
Reason: Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure.
Distribution pattern: Worldwide Distribution

5 products in this recall

VITROS® 3600 Immunodiagnostic System Product Usage: For use in the in vitro quantitative…

Product: VITROS® 3600 Immunodiagnostic System Product Usage: 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: 173
Codes and lots: Serial number range: 36000467 - 36000639
Recall started: March 15, 2012
Device type: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Ortho Clinical Diagnostics (OCD) sent an Important Product Correction Notification letter dated March 15, 2012 via FedEx overnight courier to all affected customers. Foreign affiliates were informed by email on 15 March 2012 of the issue and instructed to notify their consignees of the issue and actions. The letter identified the affected products, problem and actions to be taken. The letter instructed customers to: 1) Consider performing the backup procedure more frequently to help prevent the loss of data on your system; 2) Contact OCD Customer Technical Service representatives if a hard drive failure occurs on your system; A Field Engineer will be dispatched to replace the hard drive on your system; 3) Complete and return the Confirmation of Receipt form upon receipt of this notification; and 4) Post this notification by each VITROS System in your facility or with the user documentation. For questions, refer to the Questions and Answers section. For additional questions, contact Customer Technical Services at 1-800-421-3311.
Recall number: Z-1468-2012

VITROS® 4600 Chemistry System…

Product: VITROS® 4600 Chemistry System, Product Code: 6802445 Product Usage: 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 immuno rate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)
Quantity: 50
Codes and lots: Serial number range: 46000108 - 46000157
Recall started: March 15, 2012
Device type: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Ortho Clinical Diagnostics (OCD) sent an Important Product Correction Notification letter dated March 15, 2012 via FedEx overnight courier to all affected customers. Foreign affiliates were informed by email on 15 March 2012 of the issue and instructed to notify their consignees of the issue and actions. The letter identified the affected products, problem and actions to be taken. The letter instructed customers to: 1) Consider performing the backup procedure more frequently to help prevent the loss of data on your system; 2) Contact OCD Customer Technical Service representatives if a hard drive failure occurs on your system; A Field Engineer will be dispatched to replace the hard drive on your system; 3) Complete and return the Confirmation of Receipt form upon receipt of this notification; and 4) Post this notification by each VITROS System in your facility or with the user documentation. For questions, refer to the Questions and Answers section. For additional questions, contact Customer Technical Services at 1-800-421-3311.
Recall number: Z-1469-2012

VITROS® 5600 Chemistry System…

Product: VITROS® 5600 Chemistry System, Product Code: 6802413 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.
Quantity: 417
Codes and lots: Serial number range: 56001033 - 56001449
Recall started: March 15, 2012
Device type: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Ortho Clinical Diagnostics (OCD) sent an Important Product Correction Notification letter dated March 15, 2012 via FedEx overnight courier to all affected customers. Foreign affiliates were informed by email on 15 March 2012 of the issue and instructed to notify their consignees of the issue and actions. The letter identified the affected products, problem and actions to be taken. The letter instructed customers to: 1) Consider performing the backup procedure more frequently to help prevent the loss of data on your system; 2) Contact OCD Customer Technical Service representatives if a hard drive failure occurs on your system; A Field Engineer will be dispatched to replace the hard drive on your system; 3) Complete and return the Confirmation of Receipt form upon receipt of this notification; and 4) Post this notification by each VITROS System in your facility or with the user documentation. For questions, refer to the Questions and Answers section. For additional questions, contact Customer Technical Services at 1-800-421-3311.
Recall number: Z-1470-2012

VITROS® 5,1 FS System…

Product: VITROS® 5,1 FS System, Product Codes: 6801375 & 6801890 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.
Quantity: 120
Codes and lots: Serial number range: 34002115 - 34002243
Recall started: March 15, 2012
Device type: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Ortho Clinical Diagnostics (OCD) sent an Important Product Correction Notification letter dated March 15, 2012 via FedEx overnight courier to all affected customers. Foreign affiliates were informed by email on 15 March 2012 of the issue and instructed to notify their consignees of the issue and actions. The letter identified the affected products, problem and actions to be taken. The letter instructed customers to: 1) Consider performing the backup procedure more frequently to help prevent the loss of data on your system; 2) Contact OCD Customer Technical Service representatives if a hard drive failure occurs on your system; A Field Engineer will be dispatched to replace the hard drive on your system; 3) Complete and return the Confirmation of Receipt form upon receipt of this notification; and 4) Post this notification by each VITROS System in your facility or with the user documentation. For questions, refer to the Questions and Answers section. For additional questions, contact Customer Technical Services at 1-800-421-3311.
Recall number: Z-1471-2012

VITROS® 5,1 FS Refurbished System…

Product: VITROS® 5,1 FS Refurbished System, Product Codes: 6801375 & 6801890 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.
Quantity: 25
Codes and lots: 34000193; 34000318; 34000360; 34000420; 34000451; 34000478; 34000495; 34000497; 34000529; 34000538; 34000552; 34000596; 34000761; 34000799; 34000833; 34000947; 34001218; 34001243; 34001422; 34001504; 34001569; 34001572; 34001633; 34001633; 34001875
Recall started: March 15, 2012
Device type: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Root cause (FDA): Nonconforming Material/Component
What the company told customers: Ortho Clinical Diagnostics (OCD) sent an Important Product Correction Notification letter dated March 15, 2012 via FedEx overnight courier to all affected customers. Foreign affiliates were informed by email on 15 March 2012 of the issue and instructed to notify their consignees of the issue and actions. The letter identified the affected products, problem and actions to be taken. The letter instructed customers to: 1) Consider performing the backup procedure more frequently to help prevent the loss of data on your system; 2) Contact OCD Customer Technical Service representatives if a hard drive failure occurs on your system; A Field Engineer will be dispatched to replace the hard drive on your system; 3) Complete and return the Confirmation of Receipt form upon receipt of this notification; and 4) Post this notification by each VITROS System in your facility or with the user documentation. For questions, refer to the Questions and Answers section. For additional questions, contact Customer Technical Services at 1-800-421-3311.
Recall number: Z-1472-2012

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

Source: FDA · Medical device enforcement reports, recall numbers Z-1468-2012, Z-1469-2012, Z-1470-2012, Z-1471-2012, Z-1472-2012. The agency record governs; check it and the company before acting.

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