Fisher Diagnostics Recalls FDP Assay Kits Due to False Negative Risk
Fisher Diagnostics is recalling Pacific Hemostasis FDP Assay Kits and Latex Reagents because reduced sensitivity may cause false negative results at low FDP levels.
What this means for you
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 involves a risk-of-harm product (medical diagnostic) where the hazard is false negative results, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Fisher Diagnostics, a division of Fisher Scientific Company LLC, is recalling the Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (REF/Model 100650) and FDP Latex Reagent (REF/Model 100651). The recall involves 331 units of the assay kit, specifically Lot 948546 with an expiration date of 9/30/2017, and the associated FDP Latex Reagent, Lot 890199.
The recall was initiated because the kit exhibits reduced sensitivity when Fibrinogen Degradation Product (FDP) levels are less than 20 µg/ml. This issue is tied to the FDP Latex Reagent Lot 890199 and may result in false negative test results, although the kit performs accurately at FDP concentrations greater than 20 µg/ml.
The affected products were distributed nationwide in the United States, including Puerto Rico, and internationally to Colombia. Users of these products should stop using the affected lots and contact Fisher Diagnostics for further instructions.
The recalled product
- Product
- Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For
- Manufacturer
- Fisher Diagnostics
- Hazard
- Affected units
- 331
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 (2)
- Lot Number 948546
- Exp. 9/30/2017
Distribution
Part of a larger recall action
This product is one of 2 recalled by Fisher Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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