—#137113

Product

Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment prior to urine assay testing

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K063144
Affected lot / code info: Product Code: 6801876 Unique Device Identifier Numbers: 10758750001576

Why it was recalled

Software anomaly regarding urine samples that require acidified pretreatment. The software has allowed urine samples for assays that require acidified pretreatment to be metered from the same sample container as assays that required no pretreatment when the sample was programmed.

Root cause (FDA determination)

Software design

Action the firm took

Ortho Clinical Diagnostics distributed correction notification letters dated April 6, 2015, and response forms to their customers via courier service. All urine patient results that require pretreatment was advised to refer to the notice of correction for instructions. Correction notices should also be posted beside the device user documentation for easy reference. Customers were advised to complete and return the Confirmation of Receipt before April 20, 2015. Customers with questions may contact the Customer Technical Service at 1- 800-421-3311 anytime.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide, Brazil, Chile, Mexico, Australia, Hong Kong, India, Taiwan, Belgium, Denmark, France, Ireland, Italy, Portugal, Romania, Spain, Sweden and the UK.

Timeline

Recall initiated: 2015-04-06
Posted by FDA: 2015-06-08
Terminated: 2018-05-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #137113. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.