Cobas Analytical and Supply Unit recall in Canada: performance issue
In plain language
This recall involves Cobas Analytical and Supply Units sold in Canada. It's being recalled because of a potential operational software issue. Healthcare professionals should contact the manufacturer for more information.
What to do
- Stop using the product immediately.
- Contact the manufacturer for additional information.
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Affected products
Cobas E 402 Analytical Unit
Model: 09031553001
Lot: 2131-08, 2112-03, 2131-05, 2144-10
Cobas 8000 E 801
Model: 07682913001
Lot: More than 10 numbers, contact manufacturer.
Cobas E 801 Analytical Unit
Model: 08454345001
Lot: More than 10 numbers, contact manufacturer.
Cobas 8000 Core Unit
Model: 05641446001
Lot: More than 10 numbers, contact manufacturer.
Cobas Pure Sample Supply Unit
Model: 09031537001
Lot: 2142-01, 2114-04, 2146-07, 2141-08
Cobas Pro Sample Supply Unit
Model: 08464502001, 09205632001
Lot: More than 10 numbers, contact manufacturer.
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: 2131-08, 2112-03, 2131-05, 2144-10, 2142-01, 2114-04, 2146-07, 2141-08, More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 05641446001, 07682913001, 08454345001, 08464502001, 09031537001, 09031553001, 09205632001
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 Cobas Analytical and Supply Units sold in Canada. It's being recalled because of a potential operational software issue. Healthcare professionals should contact the manufacturer for more information.
What should consumers do?
Stop using the product immediately. Contact the manufacturer for additional information.
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 August 15, 2022.
Is the ROCHE DIAGNOSTICS GMBH brand affected by this recall?
Yes, ROCHE DIAGNOSTICS GMBH products are affected by this recall. This recall involves Cobas Analytical and Supply Units sold in Canada. It's being recalled because of a potential operational software issue. Healthcare professionals should contact the manufacturer for more information.