Medical Devices Recalls

Seal integrity of the blister pack may be compromised and sterility cannot be assured

Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.

Seal integrity of the blister pack may be compromised and sterility cannot be assured

Seal integrity of the blister pack may be compromised and sterility cannot be assured

There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl Transferase.

Seal integrity of the blister pack may be compromised and sterility cannot be assured

Seal integrity of the blister pack may be compromised and sterility cannot be assured

There is a risk for a false mutation positive result in rare cases resulting from a fluorescence artefact. In these rare cases, the controls pass correctly, while a fluorescence artefact in the mutation assay causes an incorrect valid mutation positive result.

The bracket torque was mislabeled on the packaging.

The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.

There is potential for the plastic optical tip to become detached from the metal shaft.

A manufacturing error resulted in out of specification R3 Acetabular Shells

There is a potential for the surgical system to detach from the operational room table unexpectedly. This could result in the surgical system falling onto the patient resulting in blunt injury [hemorrhage, hematoma, bleeding, or fracture(s)]

potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray.

Incorrect IOL diopter

Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility and risk of infection. Certain features on the trays with handling and storage may cause these holes.

Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.

Artis systems containing a Multi Display Manager of a specific lot, the power distributor may lead to an increased electrical contact resistance or the interruption of electrical contact, and result in planned procedures to be terminated and performed on an alternative x-ray system

There is potential for the plastic optical tip to become detached from the metal shaft.

The recalling firm confirmed that BD FACS Sample Prep Assistant (SPA) II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in the Instructions for Use (IFU). When the probe is worn, particles from the rubber cap are more likely to clog the probe, resulting in blocked or inadequate sample dispense.