Recalls / —
—#109085
Product
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 product code
- JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Device class
- Class 1
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K081543
- Affected lot / code info
- Product code: 6802413; Serial numbers: 56000118 - 56001498
Why it was recalled
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.
Root cause (FDA determination)
Software design
Action the firm took
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
Recalling firm
- Firm
- Ortho-Clinical Diagnostics
- Address
- 1000 Lee Road, Rochester, New York 14606
Distribution
- Distribution pattern
- Worldwide Distribution - US (nationwide)
Timeline
- Recall initiated
- 2012-04-26
- Posted by FDA
- 2012-06-01
- Terminated
- 2018-07-05
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #109085. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.