Complete FDA and NHTSA recall records dated in April 2019.
These records include useful source details for the selected month.
The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within the device. When the Robot detects this failure, it immediately renders the device inoperable…
Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
There is the potential for debris/material to be found behind the O-rings in the neck trials.
There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
COBAS INTEGRA 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over
The luer could break and cause the device to leak or break off and get stuck in the fistula needle port rendering the port inaccessible for dialysis. As a result, the patient would need to…
The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.
Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
DualStop Caps defect causing leaks in affected product
One lot of ACUVUE OASYS for ASTIGMATISM Brand Contact lenses has the potential for a limited number of individual contact lens packages to have an incomplete packaging seal.
There is the potential for debris/material to be found behind the O-rings in the neck trials.
For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
COBAS INTEGRA 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over
The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the average position of the anatomy…
The kits were prepared with incorrect patient ID labels and may contain incorrect components.
The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product.
Theo Chocolate Sea Salt 70% Dark Chocolate Bar is recalled due to undeclared milk.
Product was recalled due to undeclared milk. The Contains statement does not list milk as an ingredient.
FDA notified the firm of positive test results for Listeria monocytogenes found in the firm.
Incorrect probiotic strain used in formulation which did not match product labeling.
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.
