Elecsys Vitamin D total II recall
Elecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190 Product Usage: This assay is intended for the quantitative…
Why was Elecsys Vitamin D total II recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
No specific lot codes. This issue affects users of the cobas e 801 module.
- Product
- Elecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190 Product Usage: This assay is intended for the quantitative…
- Recalling firm
- Roche Diagnostics Corporation
- Quantity
- 347 units
- Distribution
- US Nationwide distribution.
- Recall date
- July 18, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)