Device 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.
Z-2154-2012
Product summary
- Event
- Event 62595
- Status
- Terminated
- Classification
- Class II
- Quantity
- 838.9 cases (1,006,700 pieces)
- Official record key
device-enforcement:Z-2154-2012
Official wording
Reason: Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.
Code information: Lot #B041206
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.