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Listeria Monocytogenes detected on food contact surfaces in Ready To Eat sandwich manufacturer facility.
Undeclared Milk.
This device does not indicate for use in patients with respiratory failure.
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.