FDA Device recall Z-2154-2012
3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110
- FDA Device
- Class II
- terminated
- Published 2012-08-15
On 2012-08-15 the FDA classified a Class II recall of 3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110 by Greiner Bio One North America, citing part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2154-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-02 |
| Published | 2012-08-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Greiner Bio One North America |
| Distribution | US |
Product
3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes.
Reason
Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.
Identifiers
| code_info | Lot #B041206 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2154-2012%22
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