Lower riskMedical device recall · FDA · Published August 9, 2023
Ortho-Clinical VITROS 5,1 Chemistry System Recall: False Test Results Risk
Ortho-Clinical recalls VITROS 5,1 chemistry system parts from April 2022 to December 2022 due to potential false test results for Gentamicin and Valproic Acid. Affected units may need replacement to prevent inaccurate patient results.
Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactured between 07-Apr-2022 (Date code: 040722) and 19-Dec-2022 (Date code: 121922) may not perform as intended due to an out-of-specification barrel component. This may cause VITROS VersaTips and/or VITROS MicroTips to be improperly seated on the proboscis, which may result in falsely elevated Gentamicin and Valproic Acid assay results as well as an increased frequency of condition codes resulting in delayed patient results. The issue was identified by internal testing when reported instruments failed to pass release testing and were traced to the molded Proboscis part J56639 with date codes from 040722 onward.
Take action
Contact the company
📍Recalling firmOrtho-Clinical Diagnostics, Inc.100 Indigo Creek Dr · Rochester, NY 14626-5101
✎ GovInfoNow plain-language explainer
Ortho-Clinical is recalling specific parts for VITROS 5,1 chemistry systems made between April and December 2022. These parts could cause false high results for Gentamicin and Valproic Acid tests, risking incorrect patient diagnoses if not replaced. Read more at govinfonow.com/recall/57512-ortho-clinical-vitros-5-1-chemistry-system-recall-false-test.
“Ortho-Clinical VITROS 5,1 Chemistry System Recall: False Test Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57512-ortho-clinical-vitros-5-1-chemistry-system-recall-false-test. Based on FDA recall #Z-0008-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0008-2024%22&limit=1).
The FDA announced on 2023-08-09 that Ortho-Clinical Diagnostics, Inc. is recalling Proboscis/Piston Assemblies due to a potential for falsely elevated test results. The agency issued recall number Z-0008-2024 for the Class II voluntary recall.
How to tell if you have it
Brand: Ortho-Clinical
Product: Proboscis/Piston Assembly, Part Number J55375
Date codes: 040722 through 121922
Affected systems: 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 (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Quantity: 9,860 assemblies
Distribution: Worldwide - US Nationwide distribution
The hazard
According to the FDA, certain Proboscis/Piston Assemblies manufactured between 07-Apr-2022 and 19-Dec-2022 may not perform as intended due to an out-of-specification barrel component. This defect may cause VITROS VersaTips and/or VITROS MicroTips to be improperly seated on the proboscis, resulting in falsely elevated Gentamicin and Valproic Acid assay results and delayed patient results.
Context
GovInfoNow's records show Ortho-Clinical Diagnostics, Inc. has 53 other recalls on record since 2017-07-10. Other recent recalls of similar products include Ortho-Clinical VITROS LAC Slides Recall (2025-07-29), Ortho-Clinical VITROS Ca Slides Recall (2025-07-09), and Ortho-Clinical VITROS OP Reagent Gen 15 May Cause Inaccurate Test Results (2025-06-12). Other recent recalls of similar products include Vivoo pH Test Recall (2025-11-22), Vivoo Vaginal pH Test Recall (2025-11-22), and Vivoo Protein Test Recall (2025-11-22).
How to tell if you have this one
Check if your VITROS 5,1 chemistry system has a Proboscis/Piston Assembly with part number J55375 and a date code between 040722 and 121922. The product was sold from April 2022 to December 2022.
Brand
Ortho-Clinical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Date Code
Look for the date code on the Proboscis/Piston Assembly (Part Number J55375) to confirm it falls between 040722 and 121922.
Contact Manufacturer
Reach out to Ortho-Clinical Diagnostics for guidance on replacement or repair options for affected units.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0008-2024 (August 9, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0008-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.