Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1293-2019·Announced 2019-05-15

Ortho-Clinical VITROS ECi Immunodiagnostic System Recalled for Luminometer Malfunction

Ortho-Clinical Diagnostics is recalling 25 refurbished VITROS ECi Immunodiagnostic Systems because a luminometer malfunction 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a functional malfunction (inability to process assays) rather than a direct physical or biological threat to patient safety, fitting the criteria for a moderate severity score.

Plain-English summary

Ortho-Clinical Diagnostics is recalling 25 units of the VITROS ECi Immunodiagnostic System (Product Code: 6801059). These are refurbished systems used for the in vitro quantitative, semi-quantitative, and qualitative measurement of various clinical analytes using VITROS Immunodiagnostic Products Reagents.

The recall is due to a luminometer malfunction that may cause the inability to process MicroWell assays. The affected units are those that had the Luminometer component replaced during a service-repair. The UDI for the affected product is 10758750001040.

The affected products were distributed worldwide, including the United States (nationwide) and countries such as 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. Users should contact Ortho-Clinical Diagnostics for further instructions regarding the recall.

The recalled product

Product: VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 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
Category: Medical Device — In Vitro Diagnostic Equipment
Hazard: malfunction
inability-to-process
Affected units: 25

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 →

Same manufacturer · Ortho-Clinical Diagnostics

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Same hazard · malfunction