Ortho VITROS 5600 System Recalled for Software Timing Anomaly
Ortho-Clinical Diagnostics is recalling VITROS 5600 systems due to a software defect that may cause sample aspiration errors, leading to inaccurate or contaminated test results.
What this means for you
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: The recall is classified as FDA Class II, and the hazard involves potential for erroneous or contaminated results which could lead to adverse health consequences, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Ortho-Clinical Diagnostics is recalling the VITROS 5600 Integrated System and VITROS 5600 Integrated System (refurbished) due to a confirmed software timing anomaly. The affected units are identified by specific catalog numbers and serial numbers, with software versions 3.2.2 and below.
The software defect may cause the system to unexpectedly aspirate from or dispense into an unintended sample. This malfunction can lead to erroneous or contaminated test results, which may impact clinical decision-making. The recall covers units distributed nationwide in the United States, Puerto Rico, and various foreign countries.
Healthcare facilities and laboratories should stop using the affected VITROS 5600 systems and contact Ortho-Clinical Diagnostics for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Integrated System (refurbished), Catalog Number 6802915, Unique Device Identifier No. 10758750007110; IVD.
- Manufacturer
- Ortho-Clinical Diagnostics
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)
- Software Version 3.2.2 & below
- VITROS 5600 Serial Numbers J56000024 - J56002387
- VITROS 5600 (Refurbished) US Serial Numbers: 56000186
- 56000308
- 56000315
- 56000327
- 56000339
- 56000458
- 56000559
- 56000718
- 56000727
- 56000741
- 56000747
- 56000750
- 56000786
- 56000792
- 56000824
- 56001062
- 56001235
- 56001635
Distribution
Part of a larger recall action
This product is one of 2 recalled by Ortho-Clinical Diagnostics 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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