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Presence of Particulate Matter
Salsa products are recalled due to potential contamination with wood particles.
It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.
Product contains elevated levels of lead (0.0649 mg/kg)
Product is contaminated with Listeria monocytogenes.
Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
cGMP deviations
Lack of Assurance of Sterility
Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025.
Potential for contamination with salmonella.
The referred batch was produced without the laser engraving of 7 mm.