The Recall Desk

Manufacturer

BBI SOLUTIONS OEM LTD

1 recall in our database name BBI SOLUTIONS OEM LTD as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2016-11-02

Of the 1 recalls from BBI SOLUTIONS OEM LTD we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • HighFDA (Devices)·Z-0314-2017·2016-11-02

    BBI Solutions Recalls SimpliRED D-Dimer Assay Kits Due to Performance Issues

    BBI Solutions is recalling SimpliRED D-Dimer assay kits because stability testing showed reduced sensitivity, which may cause false negative results and affect clinical decisions.

    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
    Category
    Medical Device
    Distribution
    2 states