Fisher Diagnostics Recalls FDP Latex Reagent Due to Reduced Sensitivity
Fisher Diagnostics is recalling specific lots of Pacific Hemostasis FDP Latex Reagent because reduced sensitivity may cause false negative test results.
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 a potential false negative result, 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 27 units of Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870. The affected product is identified by Lot Number 890199 with an expiration date of 6/30/2018. The recall also involves the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546.
The recall was initiated because the FDP kit exhibits reduced sensitivity when Fibrinogen Degradation Product (FDP) levels are less than 20 µg/ml. This reduction in sensitivity is tied to the specific lot of FDP Latex Reagent and may result in false negative test results, although the kit performs accurately at concentrations greater than 20 µg/ml.
The affected units were distributed nationwide in the United States, including Puerto Rico, and internationally to Colombia. Users of the product should stop using the affected lots and contact Fisher Diagnostics for further instructions.
The recalled product
- Product
- Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA
- Manufacturer
- Fisher Diagnostics
- Affected units
- 27
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 890199
- Exp. 6/30/2018
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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