FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics, Inc.: VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory.
- Recall number
- Z-0801-2021
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Product
- VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory.
- Status
- Terminated
- Initiated
- 2020-11-20
- Posted
- 2021-01-07
- Terminated
- 2023-10-24
- Reason
- 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.
- Root cause
- Software design
- 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.
- Quantity
- 40 units
- Distribution
- 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.
- Lot, serial or model codes
- enGen Laboratory Automation Systems and VITROS Automation Solutions Using All TCAutomationTM configured with Thermo Scientific Aliquoter & Labeller Module and using Software Versions 4.6 and below
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 1000136573
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28