VITROS 3600 Immunodiagnostic Systems May Cause Aspiration During Sample Processing
The VITROS 3600 Immunodiagnostic System is being recalled due to potential aspiration of sample containers during laboratory processing, which may result in erroneous 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: This is an FDA Class II recall for a medical device with potential risk of aspiration leading to erroneous test results. No reported illnesses or injuries as of the recall announcement, placing this in the risk-of-harm category per the rubric where injury has not yet been reported.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling the VITROS 3600 Immunodiagnostic System, both new and refurbished units. The recall affects 489 units worldwide, including 46 in the United States and 443 in other countries.
The systems are being recalled due to a potential for aspiration of unintended sample containers during the sampling center processing function. When aspiration occurs, it may lead to erroneous test results.
Clinical laboratories and healthcare providers using these systems should contact Ortho-Clinical Diagnostics, Inc. for information regarding this recall and necessary remedial actions. The FDA recall reference number is Z-1220-2024.
The recalled product
- Product
- VITROS 3600 Immunodiagnostic System (New and Refurbished)
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Hazard
- sample-aspiration
- erroneous-test-results
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)
- Code Information: UDI/DI: (New) 10758750002979
- (Refurbished) 10758750007103
- Serial Numbers: J36001164 through J36001692 (inclusive).
Distribution
Distributed nationwide across the United States.
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