Z-0314-2017Class II

SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the...

Name: Z-0314-2017 SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the...
Creator: Bbi Solutions Oem Ltd
Published: 2016-06-01
License: https://open.fda.gov/license/

Bbi Solutions OEM Limited / initiated 2016-06-01 / Terminated / root cause: manufacturing process

FDA source

BBI SOLUTIONS OEM LTD began a recall of 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... on 2016-06-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0314-2017
Classification: Class II
Status: Terminated
Initiated: 2016-06-01
Posted: 2016-10-27
Terminated: 2018-06-14
Recalling firm: Bbi Solutions OEM Limited
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
Product code: GHH Fibrin Split Products
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: BBI Solutions sent an Urgent Medical Device Recall letter dated June 30, 2016, to all affected customers. Customers were advised to immediately discontinue use of the product, consider the requirement for review of reported test results, complete and return the customer acknowledgement form to BBI Solutions and to complete and return the customer reconciliation form to the distributor. Customers who have forwarded product to other sites, should inform those customers of the product recall and provide them with a copy of the notice. Customers with questions were instructed to call Tel: +44(0)1382 564093.
Quantity in commerce: 420 units (183 units quarantined)
Distribution: US distribution to CT and IN
Product codes and lots: Lot Numbers containing test reagent lot # 1012-34437): BU183A, BU183B, BU184A, BU185A, BU185B Expiration Date: 31 JUL 2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0314-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0314-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-27

Product code GHH

K905643Class IIBed Red D-Dimer Whole Blood Agglutination AssayAgen Biomedical , Ltd. / cleared 1991-04-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)