FDA Device recall Z-2580-2024
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
- FDA Device
- Class II
- ongoing
- Published 2024-08-21
On 2024-08-21 the FDA classified a Class II recall of VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2 by Ortho Clinical Diagnostics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2580-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-03 |
| Published | 2024-08-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
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.
Identifiers
| code_info | Model No 1513266; UDI/GTIN# 110758750009237; Lots within expiry: 3380, 3390, 3400, 3410, 3422, 3430, 3440, 3450, 3461, 3471, 3480. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2580-2024%22
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