Medical equipment, implants, and diagnostic devices
Siemens Healthcare Diagnostics
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Roche Molecular Systems
Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves
Siemens Healthcare Diagnostics
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Siemens Healthcare Diagnostics
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Siemens Healthcare Diagnostics
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty single-use reload is fired a second time, the stapler may cut tissue but no staples will deploy from the empty reload, potentially resulting in a failed anastomosis, bleeding, tissue trauma, and the potential need to convert to an open procedure.
Siemens Healthcare Diagnostics
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Siemens Healthcare Diagnostics
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Possible false negative or false positive results due to the product being compromised during shipment.
Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing
Biomerieux
bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM (ref 30205 ; 30205-01).
When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.
Siemens Healthcare Diagnostics
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility.
Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with the inserters. As a result, inner shafts do not mate flush with the collet inserters, and splaying of the collet. If implant falls into the spinal cord may cause a spinal cord injury or Incomplete seating of the inserter to the implant could result in misalignment of the screws with the inserter screw guide, potentially causing malposition of the screws into the adjacent vertebral bodies
Siemens Healthcare Diagnostics
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing
RAYSEARCH LABORATORIES AB
Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.
Fujifilm Medical Systems U.S.A.
Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result
Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connector component which connects the tubing to the device. This damage was determined to generate the particulate matter observed and is created during the assembly process for connecting the tubing component to the Y-Connector.