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Undeclared allergens (Peanut) due to mispackaging
Undeclared sesame
Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the guidewire or embolic protection device (EPD) after successful stent deployment. The most serious potential adverse health consequence is stroke. Other risks include delay to procedure, vessel injury, vessel spasm, or stent disruption/damage necessitating additional intervention.
Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L. The maximum bias observed was -14 mmol/L, which occurred at a higher sodium concentration around 150 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
undeclared milk
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.