Stat Profile Prime® Plus Analyzer recall in Canada: Erroneous results
In plain language
This recall involves the Stat Profile Prime® Plus Analyzer and Stat Profile Prime® Plus POC Analyzer sold in Canada. It's being recalled because it may report incorrect creatinine patient results during initial use. Healthcare professionals should contact the manufacturer for more information.
What to do
- Contact the manufacturer, Nova Biomedical Corporation, for additional information.
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Affected products
Stat Profile Prime® Plus Analyzer
Model: 57400, 59508
Lot: PP1218410C, PP14210410C, PP1918190C, PP1C18130C, PP12210030C, PP12210080C, PP1420880C, PP15230050C, PP16220090C, PP1918340C, PP1419210C, PP14230260C, PP12230670C, PP18220170C, PP18220090C, PP1219230C, PP1420180C, PP1319060C, PP15230030C, PP18220130C, PP18220180C, PP19181902, PP1918321C, PP1B18340C
Stat Profile Prime® Plus POC Analyzer
Model: 63368
Lot: PP31220460C, PP33230230C
Stat Profile Prime® Plus POC Analyzer (Remanufactured)
Model: 63369
Why this matters
Erroneous patient 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: PP1218410C, PP14210410C, PP1918190C, PP1C18130C, PP12210030C, PP12210080C, PP1420880C, PP15230050C, PP16220090C, PP1918340C, PP1419210C, PP14230260C, PP12230670C, PP18220170C, PP18220090C, PP1219230C, PP1420180C, PP1319060C, PP15230030C, PP18220130C, PP18220180C, PP19181902, PP1918321C, PP1B18340C, PP31220460C, PP33230230C
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 57400, 59508, 63368, 63369
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?
Erroneous patient results
What should consumers do?
Contact the manufacturer, Nova Biomedical Corporation, 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?
Yes, there may be a health risk. Erroneous patient results
When was this product recalled?
This product was recalled on November 20, 2023.
Is the Nova Biomedical Corporation brand affected by this recall?
Yes, Nova Biomedical Corporation products are affected by this recall. This recall involves the Stat Profile Prime® Plus Analyzer and Stat Profile Prime® Plus POC Analyzer sold in Canada. It's being recalled because it may report incorrect creatinine patient results during initial use. Healthcare professionals should contact the manufacturer for more information.