All Recalls

Foreign material.

Label has a Contains statement that is missing milk and coconut (tree nut) that are declared in the ingredients statement.

Label declares butter and ghee but does not declare milk.

Lead contamination

Foreign material.

undeclared peanuts, almonds and pecans

Foreign material.

LABELING: LABEL MIX-UP.

Microbial contamination of non-sterile Products -

XXX

Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.

Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6

Potential for an incomplete seal on the packaging tray.

Potential for an incomplete seal on the packaging tray.

Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed. , because while the laser is switched on, the key can be removed from the key switch. The correction is replacement with a key switch that captures the key when in the on position.

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.