hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
PerkinElmer Life and Analytical Sciences, Wallac, OY
9 recalls • • Categories: Diagnostic Equipment, Infusion Pumps, Other Medical Devices
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information required to assess the acceptability of measured control values which may result in a delay in reporting IRT results.
There is a potential for leaking vials for certain lot numbers where, if proper attire is not used as instructed, a transient minor allergic skin reaction may result when handling leaking succinylacetone reagent vials.
Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.
Potential for errors in patient results generated by the Specimen Gate Laboratory Software.
Class I - Dangerous
The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to humid conditions, there is a risk that the axle material will corrode. Deterioration of the axle can be observed as deposits of corrosion on the defective axles. Ball bushing axles may corrode and corrosion particle may cause contamination in the wells or the corrosion will cause movement issues and possibly spillage and causing contamination of the plate wells.
Class I - Dangerous
The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to humid conditions, there is a risk that the axle material will corrode. Deterioration of the axle can be observed as deposits of corrosion on the defective axles. Ball bushing axles may corrode and corrosion particle may cause contamination in the wells or the corrosion will cause movement issues and possibly spillage and causing contamination of the plate wells.