Z-2154-2012 Class II Terminated
FDA device recall Z-2154-2012 was initiated by Greiner Bio-One North America, Inc. on Jul 2, 2012 and is designated Class II. Reason for recall: Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests. The recall status is terminated (terminated Jun 11, 2013). Affected quantity: 838.9 cases (1,006,700 pieces).
Recall Details
- Product Type
- Devices
- Report Date
- Aug 15, 2012
- Initiation Date
- Jul 2, 2012
- Termination Date
- Jun 11, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 838.9 cases (1,006,700 pieces)
Product Description
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.
Distribution Pattern
Nationwide Distribution
Code Information
Lot #B041206