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Terminated

VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory.

FDA Recall Z-0801-2021 · Posted 2021-01-07

Recalling FirmOrtho-Clinical Diagnostics, Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2020-11-20
Date Terminated2023-10-24
Product Quantity40 units

Reason for Recall

A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to results being associated with the wrong patient sample and potentially lead to inappropriate intervention with the potential for injury to the patient.

Firm Action

On November 20, 2020, the firm sent Urgent Product Correction Notification letters to affected customers to inform them of the issue. Customers were reminded to follow product labelling regarding removing all tubes before performing maintenance or initializing the Aliquoter & Labeller Module. There should never be sample tubes present when initializing the Aliquoter & Labeller module. The firm's release of TCA Software version 4.7 is the planned mitigation for this issue. If you have questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.

Root Cause

Software design

Distribution Pattern

Worldwide distribution - US Nationwide distribution including the states of CA, CO, MA, MD, NC, OH, TX, VA, VT, and Belgium, Bermuda, Canada, China, France, Italy, Japan, Mexico, Norway, Portugal, Singapore, Spain, Sweden, and United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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