Z-2580-2024Class II

VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2

Name: Z-2580-2024 VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2024-07-03
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2024-07-03 / Open, Classified / root cause: software

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2 on 2024-07-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2580-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-03
Posted: 2024-08-12
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Product code: CGN Acid, Folic, Radioimmunoassay
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.
Root cause tag: software
FDA root cause: Software Design Change
Action: 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.
Quantity in commerce: 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.
Product codes and lots: Model No 1513266; UDI/GTIN# 110758750009237; Lots within expiry: 3380, 3390, 3400, 3410, 3422, 3430, 3440, 3450, 3461, 3471, 3480.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2580-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2580-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-21	2024-08-12

Product code CGN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)