Digital RID Plate Reader and Software Product Code: AD400
The Binding Site Group
🏥 Medical Devices Class I - Dangerous
If a control ring is marked after reading, the software will not flag results that are out of the specified QC range.
All Recalls
95,089 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery.
Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.
🏥 Medical Devices Class I - Dangerous
Software error; Carestream Health Inc, received a complaint stating that when a user accidentally obtains a measurement value of 0 and corrects the value in the report, the resulting measurement unit is not displayed, i.e., centimeters or millimeters. As such, the user expects that the measurement is taken calculated in centimeters, consistent with other values in the report. In actuality, the measurement is taken in millimeters. When this updated measurement is used in an average calculation, the result appears incorrect as two measurements are interpreted as centimeters while the user corrected value is interpreted as millimeters. If the user selects a Calc Result display as Min or Max, the values are also interpreted as millimeters when centimeters were expected.
Fresenius 2008K2 Series : Hemodialysis System
Fresenius Medical Care Renal Therapies Group
🏥 Medical Devices Class I - Dangerous
When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine
🏥 Medical Devices Class I - Dangerous
The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive.
🏥 Medical Devices Class I - Dangerous
A software error caused the window/level to become the same in one series regardless if the image had different levels; image results have a washed-out grey appearance.
Fresenius 2008T Series Hemodialysis System
Fresenius Medical Care Renal Therapies Group
🏥 Medical Devices Class I - Dangerous
When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine
🏥 Medical Devices Class I - Dangerous
Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
🏥 Medical Devices Class I - Dangerous
Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
🏥 Medical Devices Class I - Dangerous
Endologix initiated a correction by updating reports for the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System).
🏥 Medical Devices Class I - Dangerous
A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of Magnetic Silica (MagSil). This is the same issue as in recall Z-2342-2016.
Beckman Coulter initiated a design change to update the Automate PC image to accommodate the operating system change to Windows 10.
Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152
Zimmer Biomet
🏥 Medical Devices Class I - Dangerous
Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery.
🏥 Medical Devices Class I - Dangerous
Complaints of sheath separation, kinking, and/or tip damage during use.
🏥 Medical Devices Class I - Dangerous
Complaints of sheath separation, kinking, and/or tip damage during use.
🏥 Medical Devices Class I - Dangerous
Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
PREMIER EHEC and PREMIER EHEC Bulk.
Meridian Bioscience
🏥 Medical Devices Class I - Dangerous
Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.
🏥 Medical Devices Class I - Dangerous
During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted.
🏥 Medical Devices Class I - Dangerous
Lack of 510k clearance for design modification.