Ortho VITROS 3600 Immunodiagnostic System Recalled for Software Timing Anomaly
Ortho-Clinical Diagnostics is recalling VITROS 3600 systems due to a software timing anomaly that may cause the device to aspirate or dispense into unintended samples, potentially leading to erroneous or contaminated 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: The recall is classified as FDA Class II. The hazard involves a risk of harm (erroneous or contaminated results) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Ortho-Clinical Diagnostics is recalling the VITROS 3600 Immunodiagnostic System, Catalog Number 6802783. The recall affects units with Software Version 3.2.2 and below, specifically Serial Numbers J36000012 through J36000933. The affected devices are used for the in vitro quantitative, semi-quantitative, and qualitative measurement of various analytes of clinical interest.
The recall was initiated because of a confirmed software timing anomaly. This defect may cause the VITROS 3600 and 5600 Systems to unexpectedly aspirate from or dispense into an unintended sample. Such errors may lead to erroneous or contaminated test results.
The recall covers 218 units distributed in the United States and 587 units distributed in foreign countries, including Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela. The distribution was nationwide in the US and included Puerto Rico. Users of these systems should contact Ortho-Clinical Diagnostics for instructions on how to address the software issue.
The recalled product
- Product
- VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.
- 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 (3)
- Software Version 3.2.2 & below
- Serial Numbers J36000012 - J36000933.Unique Device Identifier No. 10758750002979
- IVD.
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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