Device product
BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm) Catalog Number: 369714 Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations
Z-1189-2017
Product summary
- Event
- Event 76295
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,488,800 tubes
- Official record key
device-enforcement:Z-1189-2017
Official wording
Reason: A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount of buffered sodium citrate additive, an anticoagulant.
Code information: Lot 6090572
Distribution pattern: Worldwide Distribution - US Nationwide and the countries of Canada, Mexico, Indonesia
Derived failure modes
-
Unknown
A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount of buffered sodium citrate additive, an anticoagulant.