Magellan Diagnostics is recalling 1,774 LeadCare II Blood Lead Test Kits because the calibration buttons included in the kits were labeled with the wrong lot number. Specifically, buttons for lot 2333M were incorrectly labeled as lot 2323M, which can cause the testing system to malfunction or provide inaccurate readings. While no injuries have been reported, the company is asking users to stop using the affected kits to ensure patient safety.
Using a mislabeled calibration button can cause the test system to report lead levels that are either too high or too low. These incorrect results could lead to delayed medical care or inappropriate treatment for patients being screened for lead exposure.
Affected kits contain a Calibration Button incorrectly labeled as Lot 2323M instead of Lot 2333M.
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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