Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the gel, leading to incorrect or no result, or delay in result.
Due to microbial growth causing interference with interpretation.
Intermittent potential for shorter than expected clot times.
Due to complaints received associated with cracked/split test tube caps.
Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet Aggregation Kit may contain particulate matter or microbial growth.
Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet aggregation Kit, may contain particulate matter or microbial growth.
Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorrect inserts refer to updated parameters associated with new electrodes -- which have not yet been made available to users.
The plates do not have wells punched for the controls in the patient 1 area.
Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.
Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.
The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.
The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.
Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected
Due to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12% lower enzyme activity was noted.
Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected.
Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Protein S Conjugate Solution is labeled as Substrate, and the Substrate is labeled as Protein S conjugate.