VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and dat

FDA device recall Z-1728-2015 · posted 2015-06-08 · Terminated

Recall details

Recalling firm

Ortho-Clinical Diagnostics

Reason for recall

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.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

JJE

Quantity affected

2,387 units Total (987 domestically & 1400 internationally)

Distribution

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

Date initiated

2015-04-06

Date posted

2015-06-08

Date terminated

2018-05-25

Location

Rochester, NY