Consumer Product Recalls

Hazard: A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU). When this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes.

Hazard: Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose.

Hazard: Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.

Hazard: Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.

Hazard: In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

Hazard: In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

Hazard: In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

Hazard: In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

Hazard: Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is used in the home care environment. This correction is providing the home caregiver specific instructions for use.

Hazard: Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.

Hazard: Increased risk of purge leaks with Generation 1 purge cassettes.

Hazard: Product is potentially under-processed.

Hazard: Product is potentially under-processed.

Hazard: Product contains undeclared milk.

Hazard: Undeclared milk.

Hazard: Undeclared sulfites.

Hazard: Products contain cyclamates (banned sweetener)

Hazard: Products contain cyclamates (banned sweetener)

Hazard: Products contain cyclamates (banned sweetener)

Hazard: Salmonella spp. identified in finished product testing

Hazard: Foreign Object (Glass)

Hazard: Foreign Object (Glass)

Hazard: The product states wild caught marine collagen and eggshell membrane collagen in ingredient statement but does not state EGG and the specific species of FISH parenthetically or via a Contains statement.

Hazard: Packaging integrity issue that may compromise product quality .

Hazard: Packaging integrity issue that may compromise product quality .

Hazard: Packaging integrity issue that may compromise product quality .

Hazard: Packaging integrity issue that may compromise product quality .

Hazard: Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.

Hazard: cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

Hazard: cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.