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Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original recall.
Product Mix-up
contains undeclared wheat
Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results.
The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples.
Lack of assurance of sterility.
Product was made on equipment that test positive for Listeria .
Shrimp may be contaminated with Cesium-137 (Cs-137).
Potential Salmonella contamination.
Failed Dissolution Specifications