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Recall Observatory FDA recall evidence

Device product

VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2

Z-2580-2024

July 03, 2024

Class II

Product summary

Firm
Ortho-Clinical Diagnostics, Inc.
Event
Event 95020
Status
Ongoing
Classification
Class II
Quantity
18,467 units
Official record key
device-enforcement:Z-2580-2024

Official wording

Reason: 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.

Code information: Model No 1513266; UDI/GTIN# 110758750009237; Lots within expiry: 3380, 3390, 3400, 3410, 3422, 3430, 3440, 3450, 3461, 3471, 3480.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.