Ortho-Clinical Diagnostics Recalls VITROS CA 125 II Calibrators
Ortho-Clinical Diagnostics is recalling VITROS CA 125 II Calibrators due to a positive shift in patient 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 involves a medical device defect that affects the accuracy of diagnostic results (positive shift), which poses a risk of harm through misdiagnosis, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ortho-Clinical Diagnostics has issued a Product Correction Notification for VITROS CA 125 II Calibrators. These products are used for the calibration of VITROS ECi/ECiQ, 3600, and 5600 Immunodiagnostic Systems to measure OC 125 defined antigen in human serum and plasma.
The recall was initiated due to a positive shift in patient results. The affected units include 601 calibrators with product code 680 0034 and lot numbers 1220, 1230, 1240, and 1250.
The products were distributed worldwide, including nationwide in the United States and in various international countries. Healthcare facilities and laboratories should stop using the affected calibrators and contact the manufacturer for further instructions.
The recalled product
- Product
- VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System for the quantitative measurement of OC 125 defined antigen in human serum and plasma (EDTA or…
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
- Affected units
- 601
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 (5)
- product code: 680 0034
- Lot numbers 1220
- 1230
- 1240
- 1250
Distribution
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