Health Canada — Medical Devices · Canada · 2018-08-17 · Type II
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Reported risk: Accelerated stability testing of Fluorocell PLT stain lots A7125 through A8007 began to show decreased absorbance values after 55 days at 45 degrees Celsius which is equivalent to three months stability. The magnitude of the decrease in absorbance at 55 days, and again at 109 days (equivalent to 6 months stability) predicted that twelve lots of Fluorocell PLT would not meet the 12-month expiration dating. There is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF %) results performed using affected lots of Fluorocell PLT may exhibit lower than expected PLT-F and IPF values on the XN-Series analyzers. The issue may be recognized by a large discrepancy between the Impedance platelet (PLT-I) value and a false low PLT-F value. In most cases, the falsely decreased PLT-F results displayed a "PLT Abn Scattergram" message with asterisks beside the results indicating the data is unreliable. In rare instances, platelet flags may be absent. The PLT-I counts are unaffected.
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