FDA Enforcement
Class II
Ongoing
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Recall: Z-2580-2024
·
Reported August 21, 2024
Enforcement
- Recall Number
- Z-2580-2024
- Event ID
- 95020
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Ortho-Clinical Diagnostics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 21, 2024
- Initiation Date
- July 3, 2024
- Classification Date
- August 12, 2024
- Address
- 100 Indigo Creek Dr, Rochester, NY, 14626-5101, United States
Description
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.
Code Info
Model No 1513266; UDI/GTIN# 110758750009237; Lots within expiry: 3380, 3390, 3400, 3410, 3422, 3430, 3440, 3450, 3461, 3471, 3480.
Distribution
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