Ortho-Clinical Diagnostics Recalls VITROS 3600 Immunodiagnostic System Software
Ortho-Clinical Diagnostics is recalling VITROS 3600 Immunodiagnostic System units due to a software anomaly that may incorrectly extend reagent stability time.
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: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 682 units of the VITROS 3600 Immunodiagnostic System, Version 3.3.1 and below. The recall is due to a software anomaly that may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
The affected devices are used for the in vitro quantitative measurement of various analytes in biological fluids such as serum, plasma, urine, and cerebrospinal fluid. The recall covers units distributed nationwide in the United States.
Healthcare facilities and users should stop using the affected software versions and contact Ortho-Clinical Diagnostics for further instructions on remediation or replacement.
The recalled product
- Product
- VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
- Manufacturer
- Ortho-Clinical Diagnostics
- Affected units
- 682
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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Similar recalls
- ModerateOrtho VITROS 3600 Immunodiagnostic System Software Recall
FDA (Devices) · 2014-08-13
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