Lsi Medience Recalls Pathfast D-Dimer Test Cartridges Due to Sensitivity Issues
Lsi Medience Corporation is recalling 42 boxes of Pathfast D-Dimer test cartridges due to complaints about decreased sensitivity in control and calibration values.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a performance issue (decreased sensitivity) without reporting any patient injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Lsi Medience Corporation is recalling 42 boxes of Pathfast D-Dimer test cartridges, reference number PF1051-KUS, lot T528. Each box contains 60 test cartridges, with each kit consisting of 10 reagent cartridge trays, and each tray holding 6 cartridges.
The recall was initiated after two complaints were received regarding a decrease in the sensitivity of the product, specifically affecting the control value and/or calibration value. This issue may impact the accuracy of the test results.
The affected product was distributed in the United States to the states of Alabama (AL), Florida (FL), Idaho (ID), and Massachusetts (MA). Users of this product should stop using the recalled cartridges and contact Lsi Medience Corporation for further instructions or a replacement.
The recalled product
- Product
- Pathfast D-Dimer, Reference number: PF1051-KUS
- Manufacturer
- Lsi Medience Corporation
- Hazard
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 (1)
- Lot T528
Distribution
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