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.
Reported: August 15, 2012 Initiated: July 2, 2012 #Z-2154-2012
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.
Details
- Recalling Firm
- Greiner Bio-One North America, Inc.
- Units Affected
- 838.9 cases (1,006,700 pieces)
- Distribution
- Nationwide Distribution
- Location
- Monroe, NC
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Greiner Bio-One North America, Inc.. Units affected: 838.9 cases (1,006,700 pieces).
Why was this product recalled? ▼
Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 15, 2012. Severity: Moderate. Recall number: Z-2154-2012.
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