Z-2580-2024 Class II Ongoing
FDA device recall Z-2580-2024 was initiated by Ortho-Clinical Diagnostics, Inc. on July 3, 2024 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 18,467 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 21, 2024
- Initiation Date
- July 3, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,467 units
Product Description
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Reason for Recall
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.
Code Information
Model No 1513266; UDI/GTIN# 110758750009237; Lots within expiry: 3380, 3390, 3400, 3410, 3422, 3430, 3440, 3450, 3461, 3471, 3480.