Diagnostic Control Material Outside Expected Range, Potential for Delayed Results
Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 Immunodiagnostic Controls that may be outside the expected control range, potentially delaying diagnostic test results in laboratory systems.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall without any reported hospitalizations, illnesses, or injuries. The hazard is operational—potential delays in diagnostic test results—rather than direct patient harm. Per the rubric, Class II recalls without reported harm are scored as Moderate.
Plain-English summary
Ortho Clinical Diagnostics Inc is recalling VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (Product Code 6199966). These materials are quality control products used by clinical laboratories to verify that VITROS diagnostic testing systems are functioning properly.
The controls may fall outside the expected control range, which could affect the reliability of performance monitoring and potentially result in delayed diagnostic test results. This issue affects Lot Number 0040 and potentially future lots with an expiration date of 19 November 2021.
The recalled controls were distributed in the United States (64 units) to Alabama, Arizona, Arkansas, California, Colorado, DC, Florida, Idaho, Kansas, Kentucky, Louisiana, Maine, Michigan, Mississippi, Missouri, New York, Tennessee, Texas, and West Virginia. International distribution (200 units) occurred in Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, the United Kingdom, France, Germany, Italy, Spain, Portugal, Russia, Denmark, Norway, Sweden, Belgium, and The Netherlands.
Laboratories should identify any of these controls in their inventory using the lot number and expiration date. Contact Ortho Clinical Diagnostics for information about replacement controls or corrective actions. Additional details are available from the FDA.
The recalled product
- Product
- VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used with the VITROS Immunodiagnostic Products…
- Manufacturer
- Ortho Clinical Diagnostics Inc
Distribution
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