Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
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Diagnostic Equipment
🏥 Medical Devices • 6,554 recalls
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684
Randox Laboratories
Class I - Dangerous
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
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) Catalog Number: 6802892
Ortho-Clinical Diagnostics
Class I - Dangerous
Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results
Class I - Dangerous
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.
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
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.