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Inoperable Device - Potential for delay in therapy or prevention of defibrillation therapy due to corrosion of the Printed Circuit Board Assemblies (PCBA).
Good Manufacturing Practices (GMP) deficiencies may compromise the safety and effectiveness of the device. Firm is on import alert 89-04 and released product.
Beckman Coulter incorrectly shipped Access Hybritech PSA calibrators containing dual calibration cards (Hybritech and WHO) to some Access Hybritech PSA Customers. The WHO calibration for PSA is not currently approved in the United States.