Medical Devices Recalls

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Risk of Sling Clip breakage while in use with obsolete Flat Dynamic Positioning System (DPS)

Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MAX System may be mislabeled. This could result in a kit containing two pouches of N1 master mix or two pouches of N2 master mix, instead of one pouch of each. If laboratory personnel do not notice that both pouches contain tubes with the same color foil seal and use two of the same tubes, there is a low potential for a false negative SARS-CoV-2 result. A false negative SARS-CoV-2 result could lead to an increased risk of disease progression for the patient and additional spread of SARS-CoV-2 if the patient is not quarantined.

The manufacturer discovered an issue associated with the EPIQ Image Boost with xPlane and Color Flow or Doppler while using the X8-2t TEE Transducer. If Image Boost is enabled the color box shows flow visualization not accurately represent the fluid flow. Similarly, if Image Boost is enabled, both CW and PW Doppler traces will not accurately represent the fluid flow.

Control panel arm assembly could have missing or loose screws where undue force, pressure or weight is applied, the control panel mechanism can fail and break off.

Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach

Multirall Q-link strap lock has not been fully engaged in the S65 rail carriage hook by user, leading to the Multirall lift becoming detached from the rail system, potentially resulting in the fall of both the lift motor and the patient

Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of restart attempts at a rate substantially higher than pump in the overall population.

A failure can occur if the user attempts to remove the device by partially snipping the edge and pulling on it. The device may tear into two pieces with a portion remaining in place, which can continue to constrict the vessels. This type of failure can result in digit ischemia.

Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing.

Bottles Missing Product Label

Users cannot complete testing due to a sign-error in the software component that controls the filter movement and results in an instrument failure and assay failure before results are generated.

Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned values.

Potential for the battery to lose its ability to be recharged.

Harmony RS integrations with Topcon equipment, TRC NW-400 and the Signal Camera, allowed user input of non-unique patient IDs that caused multiple patient records and images to be combined under the first generated record

The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.

Due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile strength. This could potentially lead to intra-operative and post-operative complications such as suture break or wound dehiscence.

QIAGEN has become aware of the potential for false positive results to occur with some patient samples.

Missing Instruction For Use insert.