🏥 Medical Devices • 6,554 recalls
Randox Laboratories
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Randox Laboratories
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
Detect Headquarters
There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of supportive treatment and lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Beckman Coulter
Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN 800-7212
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
As the temperature and time out of range was exceeded, product performances cannot be guaranteed