Vacuette 2 ml Lithium Heparin, Collection Tube, Manufactured by: Greiner-Bio One North America, Inc., 4238 Capital Drive, Monroe, NC. Venous blood collection tubes.
- Recall Initiated
- August 25, 2010
- Posted
- December 16, 2010
- Terminated
- May 15, 2012
- Recall Number
- Z-0623-2011
- Quantity
- 18 cases (total 21,600 pieces)
- Firm Location
- Monroe, NC
Reason for Recall
Lithium heparin solution was contaminated by EDTA K (potassium) solution due to an operator error and a misinterpretation of a test result. Contaminated tubes will produce inaccurate test results.
Distribution
Nationwide Distribution: USA, including the states of CA, FL, IL, IN, KS, KY, ND, NE, NH, OH, SC, SD and WI.
Lot / Code Info
Item number: 454237, Lot number: B061006
Root Cause
Other
Action Taken
Greiner Bio-One instructed customers to stop distribution and to complete an attached Product Disposition form and return it via fax to Greiner Bio-One. They were further instructed to destroy any product they may have. Distributors were instructed provide a list of their customers that have received the affected item via Excel file so that they can be notified of the recall.
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