—#135517

Product

VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.

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: 6802445 Unique Device Identifier No.: 10758750012343

Why it was recalled

Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased patient results.

Root cause (FDA determination)

Software design

Action the firm took

On April 6, 2015, Ortho Clinical Diagnostics distributed correction notification letters 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..***CAPA***Since the Assay Data Disk (ADD) provides data tables that determine which assays can be tested from the same sample container, an updated ADD is being created to address the anomaly on the VITROS 4600 and 5600. The anomaly will be addressed with an updated ADD is uploaded and the revised ADD mitigates the issue totally. Anticipated date of availability TBD.

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: 2015-06-09
Terminated: 2018-05-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #135517. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.