VITROS 5600 Integrated System Software Version 1.6 & Below 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.
FDA Recall Z-1699-2012 · Posted 2012-06-01
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Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeJJE
Date Initiated2012-04-26
Date Terminated2018-07-05
Product Quantity1357 units
Reason for Recall
Ortho Clinical Diagnostics is recalling VITROS 5600 Integrated System Software Version 1.6 and below because of an anomaly that may inadvertently add a surfactant to a CurveTip position.
Firm Action
Ortho Clinical Diagnostics (OCD) sent an Urgent Product Correction Notification letter dated April 26, 2012, via FedEx overnight courier to US consignees with VITROS 5600 Systems. The letter identified the affected product, problem and actions to be taken. Foreign affiliates were informed by email on April 26, 2012 of the issue and instructed to notify their consignees of the issue and actions. OCD recommend customers to group all DAT assays into a single run as described in the letter, until the next Software Version 2.0 is installed on their VITROS 5600 System. Customers were instructed to complete and return the Confirmation of Receipt form. For questions contact Customer Technical Services at 1-800-421-3311
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - US (nationwide)
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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