Pet food and pet product recalls

Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).

Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).

Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).

Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).

Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).

Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).

Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

Undeclared milk allergen

The legs of the plush toy can detach from the body allowing the release of small beads that are on the legs, posing a choking hazard to young children.

There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on the acquisition console (both corrected and non-corrected for attenuation).

Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.

Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.

Distribution without premarket approval/clearance.

Some of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing. This may result in delayed diagnosis, cause a delay in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters.

A manufacturing process deviation occurred which may cause spoilage or microbial contamination and affect shelf stability.

The baby loungers violate the mandatory standard for Infant Sleep Products because the sides are shorter than the minimum side height limit to secure the infant; the sleeping pad's thickness exceeds the maximum limit, posing a suffocation hazard; and the enclosed openings at the foot of the loungers are wider than allowed, posing fall and entrapment hazards to infants. The portable loungers do not have a stand, posing a fall hazard. These violations create an unsafe sleeping environment for infants, posing a risk of serious injury or death.

Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.

Undeclared sugar in finished product-primary package does not reflect the product inside bottle.

Product Contamination

Product Contamination

The recalled baby loungers violate the mandatory standard for Infant Sleep Products. The sides are too low to contain an infant. The sleeping pad is too thick, posing a suffocation hazard. The enclosed openings at the foot of the loungers are wider than allowed, posing a fall hazard and an entrapment hazard to infants. Also, the baby loungers do not have a stand, posing a fall hazard if it is used on elevated surfaces. These violations create an unsafe sleeping environment for infants and can cause death or serious injury to infants. In addition, the recalled baby loungers come with crib bumpers, which are banned by the Federal Safe Sleep for Babies Act because the padded crib bumpers can obstruct breathing, posing a risk of serious injury or death to infants from suffocation.

The recalled toys violate the mandatory standard for toys containing button batteries because the compartment that holds the batteries in the remote can be accessed without the use of a common household tool. If button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal chemical burns and death.

The recalled pet toys violate the mandatory standard for consumer products containing button cell or coin batteries as required by Reese's Law because the LED-illuminated plastic sphere can break upon impact, making the button cell batteries easily accessible to children, posing an ingestion hazard. Swallowed batteries can cause serious injuries, internal chemical burns and death.

Potential contamination with floating objects

Potential contamination with floating objects

Potential contamination with floating objects

Potential contamination with floating objects

Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.

The recalled party supply toys violate the mandatory standard for toys containing button cell batteries because the compartment that holds the batteries can be easily accessed and opened by children, posing a deadly ingestion hazard to children. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.