—#131433

Product

VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System 1) VITROS 4600 - in vitro quantitative measurement of a variety of analytes, 2) VITROS 5600 - in vitro quantitative, semi-quantitative, and qualitative measurement of analytes

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K031924, K063144
Affected lot / code info: System Product Code: 1) 6802445, 2) 6802413

Why it was recalled

Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2.

Root cause (FDA determination)

Software Manufacturing/Software Deployment

Action the firm took

Ortho Clinical Diagnostics sent an Important Product Correction Notification letter dated September 29, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2. The resolution to this software anomaly will be in a future version of software. Until the new software is installed on their VITROS System, customers were instructed not to use the calibrator barcode labels for VITROS Calibrator Kit 2. Customers were advised that you manually program the calibration. Customers with questions were instructed to contact Customer Technical Services at 1-800-421-3311.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Dr, Rochester, New York 14626-5101

Distribution

Distribution pattern: Worldwide Distribution - USA including CO, NC, NJ, NY, PA, MI, WV and Internationally to Canada, Japan and Spain.

Timeline

Recall initiated: 2014-09-29
Posted by FDA: 2015-01-20
Terminated: 2017-04-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #131433. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.