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.
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.
The recalled parts have a barrel component that doesn't meet specifications. This can cause test tips to sit improperly on the assembly, leading to false high results for Gentamicin and Valproic Acid tests and more frequent errors that delay patient results.
Lab users who own VITROS 5,1 chemistry systems with the recalled Proboscis/Piston Assembly (Part Number J55375) from April 2022 to December 2022 are most at risk. Patients relying on these systems for accurate test results could be affected.
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.
Look for the date code on the Proboscis/Piston Assembly (Part Number J55375) to confirm it falls between 040722 and 121922.
Reach out to Ortho-Clinical Diagnostics for guidance on replacement or repair options for affected units.
The part may cause false elevated Gentamicin and Valproic Acid test results and more frequent errors, which could delay patient results.
Check if your Proboscis/Piston Assembly (Part Number J55375) has a date code between 040722 and 121922, indicating it was manufactured between April 2022 and December 2022.
No, the recall is for specific parts that may cause false results, not an immediate safety hazard. Continue using the system but contact Ortho-Clinical for replacement.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-0008-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-0008-2024 from Ortho-Clinical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
