BBI SOLUTIONS OEM LTD: Medical Device Recall in 2016 - (Recall #: Z-0314-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: June 1, 2016

Date Posted: November 2, 2016

Recall Number: Z-0314-2017

Event ID: 74786

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.

Status: Terminated

Product Quantity: 420 units (183 units quarantined)

Code Information:

Lot Numbers containing test reagent lot # 1012-34437): BU183A, BU183B, BU184A, BU185A, BU185B Expiration Date: 31 JUL 2016

Distribution Pattern:

US distribution to CT and IN

Voluntary or Mandated:

Voluntary: Firm initiated