Complete FDA and NHTSA recall records dated in November 2018.
These records include useful source details for the selected month.
After running the calibration curve, the recovery of the IgM kit control results decrease demonstrating a reduction in accuracy within the same day; control results may be out of range one…
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released software…
VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results
A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plots. This…
In vitro diagnostic devices, used greater than 6 months after date of manufacture, may have increased concentration times of greater than the specification of 3 hours and up to 24 hours,…
Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions.
BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical…
Potential electric leakage affecting the user.
There is a possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as intended and cause an insufficient volume of wash solution to be removed during the washing…
BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical…
Potential electric leakage affecting the user.
Potential electric leakage affecting the user.
There is an issue that could cause the Telligence System Gateway II, NGGTWY2 H, to stop communicating to the hallway devices connected to it. When this occurs, the dome lights connected to…
Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion to make the interlock system single-fault tolerant.
BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical…
Potential electric leakage affecting the user.
A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plots. This…
BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical…
Potential electric leakage affecting the user.
A safety problem with installation and maintenance could lead to the breakage of the two steel cables that support the equipment to its roof anchor. Due to this, the equipment may fall and…
The firm identified an issue with the basal calculator identified on the Android version of the Insulia application. The bug could lead from low-impact to high-impact hypoglycemia depending…
The firm noticed that multiple snack food items for a customer had the same information panel. Therefore the ingredient list and allergen information is incorrect.
The product tested positive for Salmonella.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
