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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.
Products not sterilized, sterility cannot be confirmed
Products not sterilized, sterility cannot be confirmed
Products not sterilized, sterility cannot be confirmed
Products not sterilized, sterility cannot be confirmed
Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots.
Products not sterilized, sterility cannot be confirmed
The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
Products not sterilized, sterility cannot be confirmed
Products not sterilized, sterility cannot be confirmed
Products not sterilized, sterility cannot be confirmed
Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots.
Products not sterilized, sterility cannot be confirmed
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Product failed sterility testing.
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS 3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
Invacare Homecare & G-Series Bed Components identified with a potential weld defect leads to premature weld failures to occur on these components