Class I - Dangerous
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
Class I - Dangerous
The manufacturer has identified that the use of Unsaturated Iron Binding Capacity (UBIC) lot 2690 will produce erroneously high patient results at the low end of the linear range.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
Class I - Dangerous
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
Class I - Dangerous
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
Class I - Dangerous
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
Class I - Dangerous
FDA inspection identified that due to increased positivity (false positives) on the Parvovirus B19 ELISA Test System, the firm assigned a new Correction Factor and new lot number to the remainder of the affected lot, and distributed the reworked product to the customer.
First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Number 990100B
Ameditech
Class I - Dangerous
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
Class I - Dangerous
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
Class I - Dangerous
The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.