SimpliRED D-Dimer recall
SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation…
Why was SimpliRED D-Dimer 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers containing test reagent lot # 1012-34437): BU183A, BU183B, BU184A, BU185A, BU185B Expiration Date: 31 JUL 2016
- 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…
- Recalling firm
- BBI SOLUTIONS OEM LTD
- Quantity
- 420 units (183 units quarantined)
- Distribution
- US distribution to CT and IN
- Recall date
- November 2, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)