VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Recall
- Recall Number
- Z-2580-2024
- Event Number
- 95020
- Firm
- Ortho-Clinical Diagnostics, Inc.
- FEI Number
- 1000136573
- Product Code
- CGN
- Status
- Open, Classified
- Root Cause
- Software Design Change
- Initiated
- July 3, 2024
- Posted
- August 12, 2024
- Address
- 100 Indigo Creek Dr, Rochester, NY, 14626-5101
Description
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
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.
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.
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.
18,467 units