Xpert GBS Assay recall in Canada: Medical device issue
In plain language
This recall involves the Xpert GBS Assay medical device sold in Canada. It's being recalled because of a high number of pressure abort errors observed during use. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check the lot numbers if provided.
- Contact the manufacturer for instructions.
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Affected products
Xpert GBS Assay
Model: GXGBS-100N-10
Lot: 08006, 08007, 08008, 08009, 08010, 08011, 08012, 08401, 08402, 08403, 08404, 08405, 08406, 08407, 08408, 08409, 08410, 09201, 09202
Why this matters
Medical device issue
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: 08006, 08007, 08008, 08009, 08010, 08011, 08012, 08401, 08402, 08403, 08404, 08405, 08406, 08407, 08408, 08409, 08410, 09201, 09202
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: GXGBS-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?
Medical device issue
What should consumers do?
Stop using the product immediately. Check the lot numbers if provided. Contact the manufacturer 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?
Yes, there may be a health risk. Medical device issue
When was this product recalled?
This product was recalled on February 1, 2018.
Is the Xpert brand affected by this recall?
Yes, Xpert products are affected by this recall. This recall involves the Xpert GBS Assay medical device sold in Canada. It's being recalled because of a high number of pressure abort errors observed during use. Stop using the product and follow the return steps in the official notice.