Stanbio Laboratory Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent recall — FDA Z-2199-2021
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Complete FDA and NHTSA recall records dated in August 2021.
These records include useful source details for the selected month.
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Tip of the screwdriver does not have the correct configuration / profile therefore the screwdriver does not properly fit the opposing screw head and cannot pick up the screws, may result in…
Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF…
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
There is a potential for 15% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient…
Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."
Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF…
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."
Handheld video monitor failed to meet the labeled IP67 rating which may allow fluid ingress into the monitor resulting in loss of functionality.
There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient…
Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."
Carrot products may be contaminated with Salmonella
May be contaminated with Listeria monocytogenes
Potential contamination with Salmonella in frozen cooked shrimp
Carrot products may be contaminated with Salmonella
May be contaminated with Listeria monocytogenes
Carrot products may be contaminated with Salmonella
Carrot products may be contaminated with Salmonella
Potential to be contaminated with bacteria
Carrot products may be contaminated with Salmonella
May be contaminated with Listeria monocytogenes
Carrot products may be contaminated with Salmonella
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.