Ortho-Clinical Diagnostics, Inc. has recalled 18,467 VITROS Folate Reagent Packs because a chemical reaction during the pre-treatment of patient blood samples can cause certain proteins to clump and fall out of solution. This defect triggers specific error codes on the diagnostic equipment, leading to significant delays in providing medical results. These reagent packs were distributed worldwide and in the United States, affecting 11 specific lot numbers currently within their expiration period.
The reaction between the patient samples and the stabilizer reagent can cause proteins to precipitate, which clogs the testing process and prevents the system from generating timely folate results. While no direct injuries were reported, delays in diagnostic testing can interfere with clinical decision-making and patient care.
Manufacturer Notification and Guidance
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.
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Sources: FDA iRES · Raw API Response
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