—#155157

Product

enGen Track System with TCAutomation Software Version 4.2

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: Serial numbers: 5GV6W2J, 3RHC23J, 7KSC15J, 953252, CXL941J & JG7BFB5J Product Code 952019-EG, 952020-EG, 952055

Why it was recalled

A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to patient samples being routed to an unintended location when samples are reintroduced back onto the enGEN track

Root cause (FDA determination)

Software design (manufacturing process)

Action the firm took

On 26 April 2017, Ortho Clinical Diagnostic issued a notice titled "Important Product Correction Notification" and a response form (Ref. CL2017-090) to their customers via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all potentially affected enGen customers to inform them of the issue and provide them instructions on how to monitor and correct the issue if it has occurred. Foreign affiliates were informed by email on 26 April 2017 of the issue. Potentially affected customers are those that have enGen Systems with: 1) TCA software V4.2 and configured with Rack Exit Module(s) and/or a Rack Entry & Exit (Combined) Module(s), but not configured with any ES Flex modules, and/or 2) TCA software V4.2 and a Stago analyzer with the Stago STA-R interface. **Required Actions- 1) When checking samples in the Check drawer, do the following based on your enGen System configuration: -For enGen Systems configured with Rack Entry & Exit (Combined) Module or Rack Exit Module without ES Flex, you may observe an increase in Sample IDs (SID) with General Error Duplicate SID in router messages in the Check Window. Remove the samples that are falsely identified as Duplicate SIDs from the Check drawer and reload the sample on the track for further processing if needed. NOTE: Refer to the Question and Answer section on page 3 for how to identify which samples are falsely identified as Duplicate SIDs. - For enGen Systems configured with a Stago analyzer, you may observe and increase in SIDs with "Sample not defined in router" messages for samples returning from the analyzer. Perform all post-analytical processing steps for associated samples, such as recapping, sorting and storing, off-track (manually). 2) Complete and return the attached Confirmation of Receipt form by May 9, 2017. Customers with questions may contact the Technical Solutions Center at 1-800-421-3311, 24 hours per day 7 days per week

Recalling firm

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

Distribution

Distribution pattern: Domestically - GA, IL, MO, NC & NY; Internationally - Canada, England, France, Italy & Spain

Timeline

Recall initiated: 2017-04-26
Terminated: 2021-08-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155157. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.