PTS Diagnostics, Inc. is recalling 2,452 units of its A1CNow+ Multi-Test HbA1c System because the cartridge and analyzer codes within the product box may not match. This system, which includes a monitor, test cartridges, and a blood sample dilution kit, is used to measure Hemoglobin A1C levels. While no injuries have been reported, using components from different lots together can cause the device to display inaccurate blood sugar results. The company initiated the recall after receiving complaints about the non-matching codes.
Mismatched components can cause the system to provide blood sugar readings that are falsely high or falsely low. A falsely high result (over-recovery) could lead a patient or healthcare provider to incorrectly increase therapies such as medication, physical activity, or dietary changes, which could pose health risks.
The system includes (1) a semi-disposable monitor, (2) plastic cartridges with reagent strips, and (3) a sample dilution kit.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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