There is a galling effect (cold-weld) caused by friction between the array fixation pins and the TMINI array guide holes due to insufficient clearance between the outer diameter of the fixation pins and the inner diameter of the TMINI array guide holes. As a result, the array guide has the possibility of binding to the array fixation pins during drilling.
The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. The potential impact of the defect is that erroneous test results could be reported and potentially lead to incorrect patient management of glucose control. A positive bias may be observed with eleven HbA1c affected lots. Positive bias was observed when the performance of these five HbA1c lots was compared to NGSP pooled patient target-value assigned samples and the maximum bias observed was 19%.
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.
The portable fuel containers violate the child-resistant requirements for closures under the Children's Gasoline Burn Prevention Act (CGBPA). The closure for the products is not child resistant, posing a risk of burns and poisoning to children.
Crown Boiler Company LLC, of Philadelphia, Pennsylvania
🏠 Consumer Products Class II - Moderate
The blocked vent switch (BVS) can fail to shut down the burners if the boilers are installed at altitudes above 2,000 feet and the vent system becomes blocked. In such an event, the boiler can emit excessive amounts of carbon monoxide into the building, posing a carbon monoxide (CO) poisoning hazard to consumers.
The sneaker display's magnets can forcefully attract, break, splinter and emit sparks, posing a laceration hazard. In addition, when two or more high-powered magnets are swallowed, either accidentally or intentionally, the ingested magnets can attract each other and become lodged in the digestive system. This can lead to perforations, twisting and/or blockage of the intestines that can lead to infection and death.
The product is labeled as Carrot Cake on the top but the ingredient panel on the bottom is for Chocolate Cake. The Chocolate Cake ingredient statement does not include soy which is in the Carrot Cake.