Other Medical Devices

When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.

When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (correct)

Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue that results in 2 destock transactions and 2 stock transactions, which results in doubling the bin quantity, which may result in a delay in access to desired medications and/or supplies, which may lead to temporary body function impairment.

When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.

When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.