Ortho-Clinical recalls VITROS XT 3400 Chemistry Systems with version 3.7.2 or older. These systems may report inaccurate test results due to electrical current shifts in the LED.
Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.
Ortho-Clinical is recalling VITROS XT 3400 Chemistry Systems with version 3.7.2 or older. These systems could produce inaccurate test results if a shutdown occurs, which might affect medical testing outcomes.
The system may shift electrical current to the LED during shutdown, causing positive or negative shifts in test results. This could lead to inaccurate medical test outcomes if the system is used without proper calibration.
Healthcare facilities using the VITROS XT 3400 Chemistry System with version 3.7.2 or older are most at risk. This affects labs that perform medical testing with these specific systems.
Check for the product code 6844458 on the system. Systems start with 3400XXXX where XXXX is unique for each analyzer. The software version should be 3.7.2 or older.
Verify the software version on your VITROS XT 3400 system. If it's 3.7.2 or older, it's affected.
The recall is due to potential shifts in electrical current during shutdown that could cause inaccurate test results.
Check for the product code 6844458 and software version 3.7.2 or older on your VITROS XT 3400 system.
The official recall does not specify a remedy, so contact Ortho-Clinical for guidance.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1675-2022 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1675-2022 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.
