Medical device recalls

Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.

Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.

Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.

Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.

Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.

Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.

Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.

Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.

Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner.

Instruments were developed without adequate consideration given to the need for a new regulatory filing. This event was reported to FDA as part of Stryker's retrospective review of K2M product field actions; recall actions were completed in 2017.

Mislabeled needle lengths

Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers.

After disconnection of a luer, the valve of the connector remains recessed; not fully closing, either temporarily or permanently. The risks of blood loss and air embolism exist if the valve remains permanently open and goes undetected, especially in the neonate population.

The product does not meet certain internal strength testing specifications.

The product does not meet certain internal strength testing specifications.

The incorrect sensor was used in the assembly of the camera in the scanner instrument which can potentially generate whole slide images that impact analysis algorithm results, as well as potentially impact the visual appearance of whole slide images.

The plates do not have wells punched for the controls in the patient 1 area.

AssayTips part of the AssayTip/AssayCup Tray Tips used on the cobas e 801 module- may have an Abnormal Internal Structure and lead to Incorrect patient results

Inaccurately Low Sample Results

Inaccurately Low Sample Results

GE Healthcare has become aware of a potential safety issue that can occur if the canopy seals are not cleaned appropriately. Healthcare professionals reported buildup of debris around the edge of the canopy seal which can lead to a source of infection. Upon review, the Agency concluded that the cleaning and care guidelines provided by the firm were inadequate for effective cleaning of the device. In particular, the instructions do not instruct for removal of canopy seal prior to cleaning, which leads to the buildup of debris.

Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.

Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.

The action is being initiated because the cooling indicator board was improperly installed. This was first noticed by a service employee during assembly. If for some reason the cooling of the reagent rotor fails, the reagent cooling indicator light will not illuminate and the acoustic beeper will not go off. As a consequence the operator will not be warned and the reagent storage conditions may fall out of specification.

The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.

Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).

Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).

Software malfunction; The action being taken due to the device becoming inoperable due to software lockup.

Cross contamination may have occurred between wells for the reagent pack. As a result of this defect, patient results may be negatively impacted (falsely decreased) by up to 16%).

Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14.