Becton Dickinson & Recalls

Hazard: False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.

Hazard: False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.

Hazard: False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.

Hazard: Lot has been confirmed to have no additive within the tube. Sample processed without the preservative (additive) in the tube, testing has yielded reliable results if the samples were stored at room temperature for no longer than two days. If the sample was stored for more than 2 days, the result for blood alcohol determination might not be accurate (either falsely low or falsely high)

Hazard: The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines.

Hazard: The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines.

Hazard: The products have been confirmed to have reduced or no additive within the tube reservoir. The tubes may develop visible clots within the tube samples or micro clots that are not easily detected during visual inspection of the tubes. A clotted sample may lead to recollection of samples or, retesting of patients, resulting in delayed reporting of test results and patient treatment.

Hazard: An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in faster than expected drug delivery flow when the pump is infusing.

Hazard: Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-infusion, contamination of the fluid path and HCP exposure to infusates.

Hazard: Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker.

Hazard: Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagnosis and inappropriate treatment

Hazard: Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagnosis and inappropriate treatment

Hazard: 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 be re-cannulated with a new fistula needle to obtain their dialysis treatment.

Hazard: The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product.

Hazard: The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product.

Hazard: BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record.

Hazard: False negative results with the BD MAX Extended Enteric Bacterial Panel when testing specifically for Enterotoxigenic Escherichia coli (ETEC) and Plesiomonas shigelloides targets of the BD MAX Extended Enteric Bacterial Panel assay.

Hazard: Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.

Hazard: Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.

Hazard: Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.

Hazard: a portion of a single lot was not manufactured in accordance with the internal formulation resulting in inhibited growth of Gram negative organisms.

Hazard: BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical Practice (GCP) by using microscopy to confirm an elevated RBC Count in a Urine sample as per CLSI GP16-3A. 29(4) and CAP Checklist on Urinalysis. Product will continue to ship to not impact critical patient care.

Hazard: BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical Practice (GCP) by using microscopy to confirm an elevated RBC Count in a Urine sample as per CLSI GP16-3A. 29(4) and CAP Checklist on Urinalysis. Product will continue to ship to not impact critical patient care.

Hazard: BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical Practice (GCP) by using microscopy to confirm an elevated RBC Count in a Urine sample as per CLSI GP16-3A. 29(4) and CAP Checklist on Urinalysis. Product will continue to ship to not impact critical patient care.

Hazard: BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical Practice (GCP) by using microscopy to confirm an elevated RBC Count in a Urine sample as per CLSI GP16-3A. 29(4) and CAP Checklist on Urinalysis. Product will continue to ship to not impact critical patient care.

Hazard: The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing.

Hazard: The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing.

Hazard: One lot of the specified needles is not performing as intended due to a failure in the needle tip shield/safety mechanism, which may lead to an increased risk of a contaminated needlestick injury.

Hazard: A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the presence of a Trichomonas vaginalis true positive.

Hazard: A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the presence of a Trichomonas vaginalis true positive.