Recall Z-0314-2017— BBI SOLUTIONS OEM LTD

Name: FDA recall Z-0314-2017
Creator: U.S. Food and Drug Administration
Published: 2016-06-01

Class II · Terminated

Class II FDA medical device recall by BBI SOLUTIONS OEM LTD, initiated 2016-06-01, terminated 2018-06-14. It names one FDA 510(k) clearance: K905643. Product: SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood. Reason: 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..

Recalling firm: BBI SOLUTIONS OEM LTD
Classification: Class II
Status: Terminated
Initiated: 2016-06-01
Terminated: 2018-06-14
Firm location: Dundee, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K905643 — BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAYAgen Biomedical , Ltd.·cleared 1991-04-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.