Medical Devices Recalls

There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.

The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.

The product contains a misprinted expiration date on the peel pack. Both were printed as "180615", which is the lot number. The Lot number is correct.

Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.

The sound processors were loaded with the incorrect firmware.

The sound processors were loaded with the incorrect firmware.

The labeling of the boxes and sterile pouches did not match the contents.

Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.

When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to incorrect results being generated. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, however the potential for falsely elevated results cannot be ruled out.

There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main board causing the screw to rub against the bottom side of the board, wearing away the insulation layer and creating a short circuit.

The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.

There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main board causing the screw to rub against the bottom side of the board, wearing away the insulation layer and creating a short circuit.

Lack of an adequate sterilization validation

When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to incorrect results being generated. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, however the potential for falsely elevated results cannot be ruled out.

There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main board causing the screw to rub against the bottom side of the board, wearing away the insulation layer and creating a short circuit.

Products were denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the FDA, due to the packaging being too similar to domestically sourced products under the same branded label.

Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature

The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected through the plastic housing, posing a safety hazard to the technician and potentially damaging the surrounding area.

Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch

The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.