Other Medical Devices

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.

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.

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

The firm has received 7 reports of malfunction for the device in which the hooks have broken off, potentially leading the sling to slip out of the sling bar and causing the patient to fall.

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

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

The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken.

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

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

The firm has received 7 reports of malfunction for the device in which the hooks have broken off, potentially leading the sling to slip out of the sling bar and causing the patient to fall.

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

Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product