VITROS Folate Reagent Pack (Ortho-Clinical) – Precipitation Issue (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Brand
Ortho-Clinical Diagnostics, Inc.
Lot Codes / Batch Numbers
Model No 1513266, UDI/GTIN# 110758750009237, Lots within expiry: 3380, 3390, 3400, 3410, 3422, 3430, 3440, 3450, 3461, 3471, 3480.
Products Sold
Model No 1513266; UDI/GTIN# 110758750009237; Lots within expiry: 3380, 3390, 3400, 3410, 3422, 3430, 3440, 3450, 3461, 3471, 3480.
Ortho-Clinical Diagnostics, Inc. is recalling VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2 due to It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026