Ortho-Clinical VITROS ECi/ECiQ Immunodiagnostic System Recalled for Luminometer Malfunction
Ortho-Clinical Diagnostics is recalling 45 VITROS ECi/ECiQ Immunodiagnostic Systems worldwide due to a luminometer malfunction that may prevent the processing of MicroWell assays.
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: The recall is classified as FDA Class II. The hazard is a functional malfunction (inability to process assays) rather than a direct physical injury or contamination, and no injuries or illnesses are reported in the source text.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 45 units of the VITROS ECi/ECiQ Immunodiagnostic System (Product Code: 1922814). The recall is due to a luminometer malfunction that may cause the system to be unable to process MicroWell assays. The affected systems are used for the in vitro quantitative, semi-quantitative, and qualitative measurement of various analytes of clinical interest.
The affected units were distributed worldwide, including in the United States (nationwide) and in Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and the United Kingdom. Specific serial numbers and UDI codes for the affected units are listed in the official recall documentation.
Healthcare facilities and users of the VITROS ECi/ECiQ Immunodiagnostic System should stop using the affected units and contact Ortho-Clinical Diagnostics for further instructions on the recall process.
The recalled product
- Product
- VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 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
- Hazard
- Affected units
- 45
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 (6)
- Serial Numbers: 30005946
- 30005947
- 30005948
- 30005960 through 30005975
- 30005979 30005981 through 30005991 30005993
- 30005994 30006000 through 30006005 UDI: 10758750000272
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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.
See all 7 products in this recall →Related recalls
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