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 • 6,627 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
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
Programmable Diagnostic Computer
Siemens Medical Solutions USA
Class I - Dangerous
The firm will be performing a software update to address a software error which affects the listed products. This correction addresses four potential software issues: 1) "PASSWORD STORE CORRUPTED" error message during system boot; 2) Subsystem crash during examination; 3) Dialog Monitor Computer (DMC) application crash while loading a study; and 4) Software crash due to system internal timeout. Issue 1 may lead to a delay or interruption of procedure. Issues 2, 3, and 4 may result in delay in starting or continuing the examination, and may also prevent the operator from starting or continuing a study;
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 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
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
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
As the temperature and time out of range was exceeded, product performances cannot be guaranteed