Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Anti HBs Calibrators recall — FDA Z-2142-2024
Potential for positively biased results due to signal reduction over shelf life.
Complete FDA and NHTSA recall records dated in 2024, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Potential for positively biased results due to signal reduction over shelf life.
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home…
Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit…
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home…
CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Error (MRE) which may cause tracker arrays to flicker on screen of the CORI Surgical System…
The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to…
Possibility of the robotic arm to drop more than 10cm from its original position after pressing the emergency stop button due to failure of the integrated safety mechanism.
The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home…
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home…
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home…
Possible Salmonella contamination.
Possible Salmonella contamination.
Possible Salmonella contamination.
Possible Salmonella contamination.
Possible Salmonella contamination.
Possible Salmonella contamination.
The Goat Milk Formula Recipe Kit has been sold and marketed as infant formula, but product has not submitted to FDA the premarket notification required for an infant formula for review.
Potential Salmonella Contamination.
Potential Salmonella Contamination.
Possible Salmonella contamination.
Possible Salmonella contamination.
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.