Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain product labeled as Trichosporon dermatis (T. dermatis) which may contain Candida Utilis instead of T. dermatis.
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
Biomet
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inaccurate quantitative determinations of Sex Hormone Binding Globulin in human serum and plasma.
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Analyzer's barcode reader misinterprets the contents of barcode label used for entering patient ID or accession number. The issue is related to barcode types not using a check digit. This could result in patient mixup or loss of sample resulting in delayed medical treatment
"HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use in the calibration of the Hemoglobin A1c assay.
Abbott Laboratories
Class I - Dangerous
Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The manufacturer observed no impact to assay performance between the HbA1c concentration range of 5.33% to 6.87%. However, outside of this range, a bias of greater than 3% may be seen with patient results. The device failure that is associated with this recall can result in potentially negatively and positively biased patient test results for HbA1c. The firm is investigating the root cause.
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class I - Dangerous
When the user tilts the transmitted light arm of the microscope to the end of its axis range, laser safety can be bypassed and result in emission of class lIlb laser radiation. This issue arises when a ZEISS inverted stage stand (Axio Observer or Axio Vert) is used in as a component of the LSM 700, 800 and 900 system
KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3)
Microbiologics
Class I - Dangerous
KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain product labeled as Trichosporon dermatis (T. dermatis) which may contain Candida Utilis instead of T. dermatis.
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or cartilage in orthopedic procedures. Manufactured By: Synvasive Technology, Inc., a Subsidiary of Zimmer
Synvasive Technology
Class I - Dangerous
Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm.
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class I - Dangerous
The firm received reports of a number of broken latches on the floorsitter.