Recall Z-2580-2024
Ortho-Clinical Diagnostics, Inc. · initiated July 3, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Codes / lots: Model No 1513266; UDI/GTIN# 110758750009237; Lots within expiry: 3380, 3390, 3400, 3410, 3422, 3430, 3440, 3450, 3461, 3471, 3480.
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.
FDA-determined cause: Software Design Change
Action taken
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.
Details
- Recall number
- Z-2580-2024
- Initiated
- July 3, 2024
- Posted by FDA
- August 12, 2024
- Product code
- CGN – Acid, Folic, Radioimmunoassay
- Quantity
- 18,467 units
- 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.
- Recalling firm
- Ortho-Clinical Diagnostics, Inc., Rochester, NY