VITROS Proboscis/Piston Assembly Recall for Assay Accuracy Defect
Ortho-Clinical Diagnostics is recalling 9,860 Proboscis/Piston Assemblies for VITROS diagnostic systems manufactured April-December 2022 due to a manufacturing defect that may cause falsely elevated drug assay results and delayed patient test 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: FDA Class II medical device recall with no reported illnesses or injuries. However, the known defect poses direct risk of patient harm through falsely elevated medication assay results, which could impact clinical decision-making and drug dosing decisions.
Plain-English summary
Ortho-Clinical Diagnostics is recalling Proboscis/Piston Assemblies (Part Number J55375) used in VITROS laboratory diagnostic systems. The affected assemblies were manufactured between April 7, 2022, and December 19, 2022.
These assemblies contain an out-of-specification barrel component in the molded Proboscis part. This defect may cause VITROS VersaTips and/or VITROS MicroTips to be improperly seated on the proboscis. When improperly seated, the assembly may produce falsely elevated assay results for Gentamicin and Valproic Acid, and may increase the frequency of condition codes, resulting in delayed patient test results.
Approximately 9,860 assemblies are affected. The assemblies can be identified by date code between 040722 and 121922. The affected systems have been distributed worldwide, including throughout the United States.
The recalled product
- Product
- Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System…
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Affected units
- 9,860
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 (1)
- Assemblies with a date code between 040722 - 121922
Distribution
Distributed nationwide across the United States.
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