Complete FDA and NHTSA recall records dated in January 2021.
These records include useful source details for the selected month.
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously…
Two issues: 1) 5 Lots were found to have incorrect labeling on the outer box stating that the product is CLIA Waived. 2) 3 Lots contain a kit component that expires prior to the expiration…
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously…
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously…
After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely…
A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously…
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions.
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously…
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Dirty Lens May Cause Invalid or False Positive Results
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
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.
