All Recalls

Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing

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.

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

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

Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.

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.

Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

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.

Package labeled as nitrile gloves, contains latex gloves.

It was identified that tissue culture bags were incorrectly labeled as free of phthalates.

Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots.

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the superior plate of the prodisc C device. Per the Surgical Technique, the "UP" is one of the methods used to indicate the direction in which the surgeon should place the prodisc C into intradiscal space. There are also "UP" indications in the packaging and on instrumentation as additional guides to help the surgeon properly implant the device that were present for the affected product.