Medical Devices Recalls

Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the bottle change, (when using the Standby bottle function), does not display a quality control (QC) alarm when one should be present. If the QC is out of range on the stand-by bottle and it is not removed from the system, there is a potential that when the status of the Standby bottle changes from the Standby bottle to the Current bottle status, QC alarms will not be displayed next to the sample result.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot, resulting in an incorrect flying focal spot sequence. If the system does not receive error, it would continue to complete the scan with the incorrect flying focal spot sequence, having an effect on the reconstruction of some images, resulting in image loss.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed.

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Product design change did not receive proper premarket clearance and lacks a 510 (k)

The staplers may have an insufficient firing stroke to break the washer and completely form staples.

Devices were delivered without the required dry ice.

The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.

The staplers may have an insufficient firing stroke to break the washer and completely form staples.