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All product recalls associated with Diasorin Inc..
Total Recalls
36
Past Year
0
Class I (Serious)
0
Most Recent
Nov 2024
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasorin's internal investigation determined that 0.14% of the LIAISON Q.S.E.T. Device Plus in the lots identified have loose clear caps, which may allow buffer to leak from the tube. A stool sample prepared with less than the correct amount of buffer may result an incorrectly high patient result.
DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C 136775of LIAISON HSV-2 Type Specific IgG assay may produce increased equivocal and/or false positive results.
Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.
Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value
DiaSorin Rubella IgG kits of lot 123127A were packed with one coated microtiter plate instead of two microtiter plates as indicated in the product labeling. The risk is the possibility of delayed patient test results.
The kit control provided with the GammaCoat Plasma Renin Activity kit was labeled with the incorrect range.
DiaSorin determined that there was a potential for a short to occur in a a residual starter pump electrical cable in the LIAISON (R) Analyzer.
Inaccurate measurements: Kits may sporadically recover kit and external control values out of range high.
25 Hydroxyvitamin D RIA kits may contain the incorrect lot of tracer.
A lot to lot inconsistency was noted on kits of ETI EBNA G.
Assay Failure: Assay failures may occur due to the kit control running outside of the established range (invalidating the assay)
Potential for the DiaSorin Kit 1,25-Dihydroxyvitamin D RIA Kit Control 1 (lot 548520) & 2 (lot 548521) to recover out of the defined range, LOW. (If one or both of the kit controls recover outside the defined range, the run is considered invalid)
Potential for false negative results. A software anomaly may occur when performing the ETI-Mumps IgG assay on the ETI-Max 3000 automated platform. The error occurs when running a combined plate on the ETI-Max 3000, with the ETI-Mumps IgG assay as the second assay on a combined plate with ETI-Measles IgG and/or ETI-VZV IgG.
The package insert for Hepatitis A Virus IgM antibody kit (ETI-IgMK Plus, catalog P001925), may inadvertently contain pages 5 through 12 from the instructions for Hepatitus A virus Total antibody test (ETI-AB-HAVK Plus, catalog P001926).
Package insert incorrectly states that specimen diluent is ready to use, however specimen diluent bottle in kit states that the diluent must be diluted to one liter.
Results of an internal inspection show Lot 114439E to have calibrator 1 and Calibrator 2 switched in their position in the integral. This results in an inability to calculate a curve, due to the reversal of calibrator values.
An internal inspection indicates that Calibrator 2 and Conjugate are switched in their positions in the integral. This will result in Calibrator 1 RLU's similar to that of background RLU, and Calibrator 2 RLU's near expected range. A curve can not be calculated from this data.
Expiration date of 2005/1/6 stamped on vial label of Anti-Human igG, Fluorescein Conjugate is incorrect. Correct expiration date is 2006/1/6.
QC testing of the Antibody Reagent Set for Lp(a) SPQ Test System it was discovered that the background was failing high of the specification. Through substitution testing it was determined that the Lp(a) diluent, part #238017 was the cause of the failing background specification.
DiaSorin Anti-Cardiolipin IgA Kit, catalog no. 7800, positive control was on the low limit of the acceptable range (16-35 U/mL).