VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
- Company
- Ortho-Clinical Diagnostics, Inc.
- Recall Initiated
- July 3, 2024
- Posted
- August 12, 2024
- Recall Number
- Z-2580-2024
- Quantity
- 18,467 units
- Firm Location
- Rochester, NY
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
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.
Lot / Code Info
Model No 1513266; UDI/GTIN# 110758750009237; Lots within expiry: 3380, 3390, 3400, 3410, 3422, 3430, 3440, 3450, 3461, 3471, 3480.
Root 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.