All Recalls

95,114 total recalls in our database

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

Dec 17, 2014 Prescription Drugs Nationwide View Details β†’

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

Dec 17, 2014 Prescription Drugs Nationwide View Details β†’

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

Dec 17, 2014 Prescription Drugs Nationwide View Details β†’

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

Dec 17, 2014 Prescription Drugs Nationwide View Details β†’

LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes.

Mar 13, 2015 Diagnostic Equipment View Details β†’

LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes.

Mar 13, 2015 Diagnostic Equipment View Details β†’

The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.

Feb 25, 2015 Diagnostic Equipment View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes.

Mar 13, 2015 Diagnostic Equipment View Details β†’

LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes.

Mar 13, 2015 Diagnostic Equipment View Details β†’

LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes.

Mar 13, 2015 Diagnostic Equipment View Details β†’

The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.

Feb 25, 2015 Diagnostic Equipment View Details β†’

LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes.

Mar 13, 2015 Diagnostic Equipment View Details β†’

Instrument Kits for OsteoSponge SC grafts, OsteoLock Facet Stabilization Dowel, and BacFast HD Facet Dowel have incorrect sterilization parameters in the IFU and on the lid of the kits. Sterilization parameters for the Steam Gravity 121 degree C (250 F) cycle were not validated and the dry time for the Steam Pre-Vacuum 132 degree C (270 F) cycle was omitted.

Mar 9, 2015 Implants & Prosthetics View Details β†’