GeneXpert Dx System - Xpert MRSA Assay recall in Canada: Invalid results
In plain language
This recall involves the GeneXpert Dx System - Xpert MRSA Assay sold in Canada. It's being recalled because it may produce a higher number of invalid test results than expected. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check the lot number 1000054536 (lot 20712) and model number GXMRSA-100N-10.
- Contact Cepheid for instructions.
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Affected products
GeneXpert Dx System - Xpert MRSA Assay
Model: GXMRSA-100N-10
Lot: 1000054536 (lot 20712)
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: 1000054536 (lot 20712)
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: GXMRSA-100N-10
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?
This recall involves the GeneXpert Dx System - Xpert MRSA Assay sold in Canada. It's being recalled because it may produce a higher number of invalid test results than expected. Stop using the product and follow the return steps in the official notice.
What should consumers do?
Stop using the product immediately. Check the lot number 1000054536 (lot 20712) and model number GXMRSA-100N-10. Contact Cepheid for instructions.
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?
A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.
When was this product recalled?
This product was recalled on February 1, 2018.
Is the GeneXpert Dx System brand affected by this recall?
Yes, GeneXpert Dx System products are affected by this recall. This recall involves the GeneXpert Dx System - Xpert MRSA Assay sold in Canada. It's being recalled because it may produce a higher number of invalid test results than expected. Stop using the product and follow the return steps in the official notice.