Customers shouldn’t use sure assessments manufactured by Common Meditech Inc., the US Meals and Drug Administration warned Friday, together with those who take a look at for being pregnant, ovulation and urinary tract infections.
“UMI has notified the FDA that it has stopped all operations and is now not offering assist for its assessments,” the company stated. “The FDA will not be in a position to verify the efficiency of UMI’s assessments, elevating considerations that the assessments might not be secure and efficient.”
The California-based firm has recalled undistributed assessments however not those who have already been distributed to shoppers.
Customers are suggested to not buy or use the next Common Meditech assessments however fairly to throw them away:
- One Step Being pregnant Check
- DiagnosUS One Step Ovulation Check
- HealthyWiser UriTest 10 Parameter Reagent Check Strips for Urinalysis
- HealthyWiser UriTest UTI Check Strips
- HealthyWiser KetoFast Ketone Check Strips
- HealthyWiser pH-Conscious pH Check Strips
- To Life hCG Being pregnant Urine Check
- Am I Pregnant Being pregnant Midstream Check
- DeTec hCG Being pregnant Urine Check
- PrestiBio Being pregnant Strips
- PrestiBio Fast Detection Being pregnant Check Midstream
- PrestiBio Ovulation Strips
- PrestiBio Urinalysis Check Strip 10 Parameters
- PrestiBio Ketone Check Strips
- PrestiBio Breast Milk Alcohol Check Strips
The assessments could have been distributed underneath model names comparable to AC&C, HealthyWiser, House Well being US and Status Biotech.
Anybody who has used certainly one of these assessments and nonetheless needs outcomes ought to take a look at once more with a special model and attain out to a well being care supplier if they’ve considerations about accuracy.
Customers could report issues with units or assessments to the FDA by its MedWatch program.