Ortho-Clinical recalls VITROS 4600 Chemistry Systems with software versions 3.2 to 3.8.3 due to potential erroneous test results from expired reagent packs.
a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.
Ortho-Clinical is recalling VITROS 4600 Chemistry Systems with specific software versions because a software glitch can cause the system to report reagent packs as expired even when they're not, leading to incorrect test results or delays.
The software anomaly causes the system to incorrectly flag diluent packs as expired when they're not, even if the 'Use Expired Reagents' setting is disabled. This can lead to inaccurate test results or delays in processing tests, particularly for urine tests.
Healthcare facilities using VITROS 4600 Chemistry Systems with software versions 3.2 to 3.8.3 are most at risk. This affects systems installed since April 2011.
Check if your VITROS 4600 Chemistry System has software version 3.2 to 3.8.3. The product codes are 6802445 (new) or 6900440 (refurbished), with serial numbers from 46000111 to 46001897.
Verify your system's software version is 3.2 to 3.8.3 by checking the device settings or documentation.
Install the latest software update to fix the issue, as available updates are provided by the manufacturer.
The software anomaly can cause the system to report diluent packs as expired even when they're not, leading to incorrect test results or delays in processing tests.
Systems with product codes 6802445 (new) or 6900440 (refurbished), software versions 3.2 to 3.8.3, and serial numbers from 46000111 to 46001897.
The manufacturer provides software updates to fix this issue; contact Ortho-Clinical for the latest version.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-2040-2025 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-2040-2025 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.
