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wrong product in box
Due to a software anomaly, an incorrect patient name may be transmitted with image to Odyssey workstation.
The guide pin which rotationally constrains the tibial punch within the punch guide, may fall out.
The product was labeled 'esophageal', but contained a 'biliary' ballon
Size mix-up. 13 cm product may be labeled as 21.6 mm and visaversa.
The Hyfrecator 2000 units were released without documented adherence to their voltage output specification.
possible external debris in the on/off plunger.
The laser product failed to comply with the performance standards, including certification, identification, warning logotype label, aperture label and submission of a product report.
The 400cc, 460cc, 500cc and 560cc sizes of the McGhan Style 40 Silicone-filled Breast Implants were manufactured using one size smaller shells than required.
Erroneous patient results: may be falsely elevated or lowered, due to a packaging defect that allows air and moisture to enter the sealed pouch.
Several customers complained that either the negative control index value exceeded the upper control limit or there was very low activity of the cut off calibrator causing patient sample test runs to be called invalid.
Varicella Zoster ELISA kit assay was producing invalid runs on the ETI-Max 3000 automated microtiter plate instrument and/or false negative results.
Firm received additional information from the procurement agency indicating that the donor's serological test sample may have been sufficiently diluted by transfusion/infusion to invalidate the HIV and Hepatitis B and C screening test results.
The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.