Fibrin Split Products

Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105

Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.

Pathfast D-Dimer, Reference number: PF1051-KUS

Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.

Alere Triage D-Dimer Test

Alere initiated this recall because a limited number of Alere Triage D-Dimer devices from PN 98100 Lot W53884B were incorrectly manufactured. As a result, when testing patient sample these affected devices will either generate an error code (e.g. E4 error), or they may generate an incorrect result.

Triage D-dimer PN 98100

Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing.

Minutex D-Dimer ; Trinity Biotech plc,

There is a performance issue with Minutex D-Dimer Kit which may cause false negative results for patient samples containing levels of greater than 250ng/mL D-Dimer.

Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole blood and plasma.

Lot PX018A is exhibiting a decrease in sensitivity affecting the qualitative result around the cut off.

Dade Fibrin(ogen) Degradation Products (FDP) Detection Set. Catalog number B4233-10E

positive control shows weak agglutination reaction

Pacific Hemostasis D-Dimer Assay Kit, Fisher Diagnostics Catalog Number 100660, packaged in a cardboard box containing materials and reagents to perform 80 test

Defective reagent may cause in vitro diagnostic test kit to yield false positive test results in clinical samples.

SimpliRED D-Dimer, Product Code DSRK4

A component of the kit is showing a sensitivity performance detected in stability testing at 15 months of an 18-month shelf life. Qualitative results may be affected. False negative results are possible which may incorrectly influence the clinical diagnostic decision.