3mL 9NC Coagulation Sodium Citrate 3 — Class II medical device recall Z-2154-2012
Terminated recall by Greiner Bio-One North America, Inc., reported 2012-08-15, distributed nationwide. Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for co
| Recall number | Z-2154-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Greiner Bio-One North America, Inc., Monroe, NC, United States |
| Recall initiated | 2012-07-02 |
| Classified | 2012-08-07 |
| Reported by FDA | 2012-08-15 |
| Terminated | 2013-06-11 |
| Distributed | Nationwide (US) |
| Lot numbers | B041206 |
| Model numbers | 454334 |
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 for recall
Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2154-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.