Roche recalls Vitamin D test system that may give falsely high results, risking vitamin D deficiency if users adjust doses without proper monitoring. Affected units sold with specific analyzers.
The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a dosage reduction of vitamin D supplementation cannot be excluded, and as a consequence, vitamin D deficiency may develop over time.
Roche is recalling its Vitamin D test system because it can give falsely high results. This might lead to users reducing their vitamin D supplements too much, causing deficiency over time.
The test may show higher vitamin D levels than actual. If users reduce their supplements because of this false high reading, they might not get enough vitamin D over time, leading to deficiency.
Users of the Roche Vitamin D test system with specific analyzers (MODULAR ANALYTICS E 170, cobas e 411, cobas e 601/602) who monitor vitamin D levels through lab tests. Those who adjust supplement doses based on test results are most at risk.
Look for the product name 'Elecsys Vitamin D total II' with material number 07464215160. It was sold with specific analyzers: MODULAR ANALYTICS E 170, cobas e 411, cobas e 601, and cobas e 602 modules.
Verify if your vitamin D test results have been adjusted based on this test system's readings.
Ask your lab if they used this specific test system and request a retest if results were adjusted.
No, the hazard is low risk. This test may give false high results, but it does not cause physical injury.
No, you can continue using it but should check results with your lab to ensure accuracy.
The affected analyzers are MODULAR ANALYTICS E 170, cobas e 411, cobas e 601, and cobas e 602 modules.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-2390-2018 — Roche Roche Hello, I own a Roche that is covered by recall Z-2390-2018 from Roche. 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.
