Roche recalls Vitamin D test system that may give false high results, risking vitamin D deficiency if dosage is reduced. Affected users should check if they have the specific material number.
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 reduced vitamin D supplements and potential deficiency over time. The recall affects people using this test for vitamin D levels.
The test may show higher vitamin D levels than actual. If users reduce their supplements based on this false reading, they could become deficient over time. This is a measurement error, not a safety hazard.
People who use the Roche Vitamin D test system for blood tests may be affected. Those monitoring vitamin D levels through lab tests are most at risk.
Check for the material number 07028148190 on the test system. The recall affects users of the cobas e 801 module for this specific test.
Look for the material number 07028148190 on the test system or the cobas e 801 module.
No, the hazard is a false high result that could lead to vitamin D deficiency, not a physical injury risk.
Check for the material number 07028148190 on the test system or the cobas e 801 module.
The recall does not require stopping use; check if you have the material number and consider the risk of false results.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-2389-2018 — Roche Roche Hello, I own a Roche that is covered by recall Z-2389-2018 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.
