Class II — Greiner Bio-One North America, Inc.
| Recalling firm | GREINER BIO-ONE NA |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests. |
| 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. |
| Quantity | 838.9 cases (1,006,700 pieces) |
| Distribution | Nationwide Distribution |
| Initiated | 2012-07-02 |
| Classified | 2012-08-07 |
| Terminated | 2013-06-11 |
| Recall number | Z-2154-2012 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Greiner Bio-One North America, Inc. (Z-2154-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62595/
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