Diagnostic Equipment

Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.

Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.

BD has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) of product may exhibit blue speckles or fibers on the beads and cards, as shown below. This issue would result in an invalid test, as described in the package insert.

The monitor may not alarm appropriately for a pediatric or neonatal patient.

Potential performance issues. False Susceptible result instead of Intermediate and False Intermediate result with certain methods.

CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED.

Expired expiration dates are listed on the pouches.

The device defect associated with this recall may result in HbA1c values with a negative bias in patients with the hemoglobin variants C, D, E and S. The negative bias occurs at the higher levels of HbA1c, e.g. 9%, but not at the diagnostic medical decision point of 6.5%.

Quidel Corporation is recalling Influenza Transport Swab Packages because it may include an incorrect sample swab mixed in with the proper swabs.

Expired expiration dates are listed on the pouches.

The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OPAX03 lot 802907632 that may result in erroneously reduced or elevated homocysteine values. The stability issue may lead to higher than expected lot-to-lot variation and an impaired product performance.

Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Enzyme II calibrator. Internal investigation has confirmed that patient samples and QC material demonstrate a shift of up to 10% in comparison to results obtained using earlier calibrator lots.

Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Vista Enzyme 2 calibrator. Internal investigation has confirmed that patient samples and QC material demonstrate a shift of up to 10% in comparison to results obtained using earlier calibrator lots.

The firm has become aware of a potential device issue where the LIFEPAK 15 device may no longer be able to deliver defibrillation energy due to a potential failure of an internal component (Relay) installed on the Therapy Printed Circuit Board Assembly (PCBA).

There is a remote possibility CentraLink may download an order to the ADVIA Automation System without specifying the sample type. This can occur when an order is received from the LIS without a sample type, requiring that the sample type be set in CentraLink based on the sample type of the test in the order.

Merge received reports of Merge Eye Station being unable to capture images of the eye as expected per the intended use of the product. Merge is recalling product from the field to reduce the risk to patient health.

The insert and case label description of the device incorrectly reads Counter Incrementing Actuator with 22mm O.D./I.D. Connections.

The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.

The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.

Siemens Healthcare Diagnostics has determined that Dimension AMM (DF119) flex reagent cartridge lots EB7180, FB7152, BA7194, EA7223, BA7250 do not meet the 60-day calibration interval claim due to reagent instability and results may show an Abnormal Assay.