VITROS diagnostic systems may produce erroneous results from sample container aspiration
Ortho-Clinical Diagnostics is recalling VITROS immunodiagnostic analyzer systems that may aspirate unintended sample containers during processing, potentially causing erroneous test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with no reported illnesses or injuries. Aspiration of sample containers represents a risk-of-harm product; the theoretical hazard could result in erroneous diagnostic test results.
Plain-English summary
VITROS 5600 Integrated Systems and related VITROS models (3600 and XT 7600) manufactured by Ortho-Clinical Diagnostics are being recalled due to a potential aspiration hazard during sample container processing.
The potential hazard is that unintended sample containers may be aspirated during sampling center processing, which could lead to erroneous test results.
The recall affects 1,460 units distributed worldwide. In the United States, 506 units are affected. Internationally, 954 units are affected, with distribution across Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, and the United Kingdom.
The recalled product
- Product
- VITROS 5600 Integrated System (New and Refurbished)
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI: (New) 10758750002740
- (Refurbished) 10758750007110
- Serial Numbers: J56000280
- J56000330
- J56000415
- J56000631
- J56000634
- J56000721
- J56000839
- J56000871
- J56001088
- J56001209
- J56001228
- J56001265
- J56001305
- J56001355
- J56001834
- J56001855
- J56001941
- J56001998
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Ortho-Clinical Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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Similar recalls
- HighOrtho-Clinical Diagnostics Recalls VITROS 5600 Integrated Systems
FDA (Devices) · 2018-10-17
- HighOrtho-Clinical VITROS 5600 System Recalled for Sample Dispensing Defect
FDA (Devices) · 2018-10-17
- HighOrtho VITROS 3600 Immunodiagnostic System Recalled for Software Timing Anomaly
FDA (Devices) · 2016-06-15
- ModerateOrtho-Clinical Diagnostics Recalls VITROS 5600 Systems Due to Software Error
FDA (Devices) · 2014-08-13
- SevereOrtho-Clinical VITROS XT 7600 System Recalled for Potential Sample Dispensing Errors
FDA (Devices) · 2019-05-29
- HighOrtho VITROS 5600 System Recalled for Software Timing Anomaly
FDA (Devices) · 2016-06-15