FDA · Medical device recall

VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2

Aug. 21, 2024 Class II

Date: Aug. 21, 2024
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): 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)
Status: Ongoing
Filed by: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Reason: It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the pre-treatment process causing the increase in "TM5-4MB" condition codes which lead to a delay of results.
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Sweden, United Kingdom.
Quantity: 18,467 units
Codes and lots: Model No 1513266; UDI/GTIN# 110758750009237; Lots within expiry: 3380, 3390, 3400, 3410, 3422, 3430, 3440, 3450, 3461, 3471, 3480.
Recall started: July 3, 2024
Device type: Acid, Folic, Radioimmunoassay
Root cause (FDA): Software Design Change
What the company told customers: On July 15, 2024, IMPORTANT PRODUCT CORRECTION NOTIFICATION letters were sent to customers. REQUIRED ACTION 1. Send the enclosed Customer Letter and Confirmation of Receipt form to all customers who were shipped VITROS Immunodiagnostic Products Folate Reagent Pack 1/2 from your facility within the past 12 months. 2. Complete the enclosed Confirmation of Receipt form no later than July 23, 2024. If you have further questions, please contact the Global Services Organization at 1-800-421-3311.
Recall number: Z-2580-2024

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2580-2024. The agency record governs; check it and the company before acting.

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