Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 2, 2016
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
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 nega…
Bbi Solutions Oem LTD recalled SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitativ… - a moderate-severity action.
SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitativ… was recalled by Bbi Solutions Oem LTD in November 2, 2016. Reason: A component of the kit is showing a sensitivity performance detected in stability testing at 15 months of an …. Check the official notice for the remedy. Verify recall #Z-0314-2017 with the FDA Devices before acting.
The recall
Bbi Solutions Oem LTD issued this moderate-severity FDA Devices recall-A component of the kit is showing a sensitivity performance detected in stability testing at 15 months of an ….
- Moderate
- severity level
- 420 units
- affected scope
- Class II
- classification
- November 2, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0314-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0314-2017) was formally reported on November 2, 2016, with the manufacturer initiating the action on June 1, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Bbi Solutions Oem LTD is listed as the recalling firm, operating out of Dundee. Federal records list the affected scope as 420 units (183 units quarantined).
The documented reason for this recall is: 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 inco… Distribution data in the federal record shows the product reached: US distribution to CT and IN. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
420 units (183 units quarantined)
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0314-2017 |
| Date reported | November 2, 2016 |
| Date initiated | June 1, 2016 |
| Recalling firm | Bbi Solutions Oem LTD |
| Firm location | Dundee |
| Affected scope | 420 units (183 units quarantined) |
| Distribution | US distribution to CT and IN |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0314-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Bbi Solutions Oem LTD. Units affected: 420 units (183 units quarantined).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 2, 2016. Severity: Moderate. Recall number: Z-0314-2017.
Where was the recalled product distributed? ▼
Distribution: US distribution to CT and IN.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0314-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 2, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.