VITROS® 3600 Immunodiagnostic System Product Usage: For use in the in vitro quantitative, semi-quant

FDA device recall Z-1468-2012 · posted 2012-04-26 · Terminated

Recall details

Recalling firm

Ortho-Clinical Diagnostics

Reason for recall

Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JJE

Quantity affected

173

Distribution

Worldwide Distribution

Date initiated

2012-03-15

Date posted

2012-04-26

Date terminated

2017-09-20

Location

Rochester, NY

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