VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Reported: August 21, 2024 Initiated: July 3, 2024 #Z-2580-2024
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.
Details
- Recalling Firm
- Ortho-Clinical Diagnostics, Inc.
- Units Affected
- 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.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2. Recalled by Ortho-Clinical Diagnostics, Inc.. Units affected: 18,467 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 21, 2024. Severity: Moderate. Recall number: Z-2580-2024.
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