VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2 recall
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Why was VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2 recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model No 1513266; UDI/GTIN# 110758750009237; Lots within expiry: 3380, 3390, 3400, 3410, 3422, 3430, 3440, 3450, 3461, 3471, 3480.
- Product
- VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- 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.
- Recall date
- August 21, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)