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Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS 3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.