VITROS Chemistry Products 5,1 FS Chemistry System - dLDL Assay (2018-10-08)
In plain language
This recall involves the VITROS Chemistry Products 5,1 FS Chemistry System - dLDL Assay used in medical settings. It's being recalled because it may give incorrect test results. Healthcare professionals should stop using the affected products and follow the instructions in the official notice.
What to do
- Stop using the affected products immediately.
- Check the lot numbers of your VITROS Chemistry Products 5,1 FS Chemistry System - dLDL Assay.
- Follow the instructions provided by Ortho Clinical Diagnostics.
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Affected products
VITROS Chemistry Products 5,1 FS Chemistry System - dLDL Assay
Model: 680 1728
Lot: GEN: 26-6396, GEN: 26-6639, GEN: 27-6808
Why this matters
Incorrect test results
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: GEN: 26-6396, GEN: 26-6639, GEN: 27-6808
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 680 1728
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Incorrect test results
What should consumers do?
Stop using the affected products immediately. Check the lot numbers of your VITROS Chemistry Products 5,1 FS Chemistry System - dLDL Assay. Follow the instructions provided by Ortho Clinical Diagnostics.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Incorrect test results
When was this product recalled?
This product was recalled on November 2, 2018.
Is the VITROS brand affected by this recall?
Yes, VITROS products are affected by this recall. This recall involves the VITROS Chemistry Products 5,1 FS Chemistry System - dLDL Assay used in medical settings. It's being recalled because it may give incorrect test results. Healthcare professionals should stop using the affected products and follow the instructions in the official notice.