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Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Failed Dissolution Specifications
cGMP deviations
A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.
Undeclared Milk.
Elevated levels of Lead, cadmium and arsenic
This device does not indicate for use in patients with respiratory failure.
Product contains undeclared almond and cashew.
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect.
During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error preventing user access to the dispensing software application, which may lead to delay in access to medications/supplies, and delivery/replenishment of patient specific orders; which may lead to delay in patient care.
Undeclared allergens (milk and/or peanuts).
Antivirus software was not consistently installed on impacted devices during the implementation process.
regular yeast was inadvertently packaged as nutritional yeast
Unreleased software versions were installed on distributed devices without verification or validation.
Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.
U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.