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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (false negative results influencing clinical decisions) where specific injury or illness reports are not stated in the source text.
Plain-English summary
BBI Solutions OEM LTD is recalling 420 units of the SimpliRED D-Dimer assay (Product Code DSRK4). The recall affects specific lot numbers (BU183A, BU183B, BU184A, BU185A, BU185B) containing test reagent lot # 1012-34437, with an expiration date of July 31, 2016. The affected units were distributed in Connecticut and Indiana.
The recall was initiated because stability testing at 15 months of the 18-month shelf life detected a sensitivity performance issue in a component of the kit. This issue may affect qualitative results, making false negative results possible. False negative results could incorrectly influence clinical diagnostic decisions.
Healthcare facilities and users should stop using the affected lots immediately. BBI Solutions is the recalling firm responsible for managing the recall.
The recalled product
- 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
- Manufacturer
- BBI SOLUTIONS OEM LTD
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot Numbers containing test reagent lot # 1012-34437): BU183A
- BU183B
- BU184A
- BU185A
- BU185B Expiration Date: 31 JUL 2016
Distribution
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