HITACHI HICO Creatinine Jaffe Method recall in Canada: inaccurate results
In plain language
This recall involves HITACHI HICO Creatinine Jaffe Method products used in medical testing in Canada. They are being recalled because they may give inaccurate results for creatinine levels due to interference from other substances. Healthcare professionals should stop using the affected products and follow the instructions from the manufacturer.
What to do
- Stop using the affected products immediately.
- Check the lot and model numbers of your products.
- Follow the instructions provided by Roche Diagnostics GMBH.
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Affected products
HITACHI HICO Creatinine Jaffe Method, Rate-Blanked & Compensated (CREA) CREJ2 cobas c 111
Model: 11875418216, 11875663216, 11929941216
Lot: 21135801, 22521601, 23333001, 24018201, 24724601, 25179801, 28039501, 29422901, 33545001
CREJ2 cobas c 111
Model: 05401755190
Lot: 23421901, 26739801, 31788801, 35247501
CREJ2, cobas c 701/702
Model: 06407137190
Lot: 24327001, 25635101, 27623601, 29187701, 31403501, 32683201, 34583301, 35712601, 37008301
CREJ2 cobas c 311/501/502/ COBAS INTEGRA 400 plus
Model: 04810716190
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Inaccurate medical 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: 21135801, 22521601, 23333001, 24018201, 24724601, 25179801, 28039501, 29422901, 33545001, 23421901, 26739801, 31788801, 35247501, 24327001, 25635101, 27623601, 29187701, 31403501, 32683201, 34583301, 35712601, 37008301, More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 04810716190, 05401755190, 06407137190, 11875418216, 11875663216, 11929941216
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?
Inaccurate medical test results
What should consumers do?
Stop using the affected products immediately. Check the lot and model numbers of your products. Follow the instructions provided by Roche Diagnostics GMBH.
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. Inaccurate medical test results
When was this product recalled?
This product was recalled on March 1, 2019.
Is the HITACHI HICO brand affected by this recall?
Yes, HITACHI HICO products are affected by this recall. This recall involves HITACHI HICO Creatinine Jaffe Method products used in medical testing in Canada. They are being recalled because they may give inaccurate results for creatinine levels due to interference from other substances. Healthcare professionals should stop using the affected products and follow the instructions from the manufacturer.