Ortho-Clinical recalls VITROS XT 7600 systems with software version 3.7.2 or older. These systems may report inaccurate test results due to electrical current shifts in the LED. Affected units have product code 6844461.
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 7600 laboratory analyzers with software version 3.7.2 or older. The recall happens because these systems might give incorrect test results due to electrical current shifts in the LED. This could affect medical testing accuracy.
The system may shift electrical current to the LED in the Digital Imaging Reflectometer during shutdown. This shift can cause the system to report either higher or lower test results than actual. The issue affects accuracy but not safety.
Lab technicians and healthcare facilities using the VITROS XT 7600 system with software version 3.7.2 or older are affected. Those performing medical tests with this equipment are most at risk of inaccurate results.
Check the system's software version on the label. Affected units have product code 6844461 and start with the serial number 7600XXXX.
Look for the software version on the system label; affected units have version 3.7.2 or older.
The system may report incorrect test results due to electrical current shifts in the LED during shutdown.
Check the software version on the label; affected units have version 3.7.2 or older and product code 6844461.
Check the software version and product code. If affected, 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-1676-2022 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1676-2022 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.
