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CGMP Deviations
undeclared milk allergen
There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.
International Motors, LLC (International) is recalling certain 2025-2026 HV, HX, LT, MV, RH, and 2025 EMV vehicles. The linkage that connects the right-side wiper arm to the motor may separate, causing the wipers to fail.
A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
Potential breach of sterile barrier packaging.
Ford Motor Company (Ford) is recalling certain 2015 F-250, F-350, F-450, Expedition, Lincoln Navigator, and MKC vehicles. The rearview camera printed circuit board terminal header connector may be loose or damaged, which can result in a blank or distorted image.
The MIRA Surgical System Software Version 4.0.3 loaded on the Surgeon Control Console may have the potential to exhibit interrupted motion on the display screen, caused by a software latency between the movement of the hand controllers and the movement of the Surgical Minibot arms.
The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.
A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
Due to printing quality, label does not declare Egg allergen clearly.