Recall Z-0623-2011 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Greiner Bio-One North America, Inc.
Vacuette 2 ml Lithium Heparin, Collection Tube, Manufactured by: Greiner-Bio One North America, Inc., 4238 Capital Drive, Monroe, NC. Venous blood collection tubes.
| Date | Dec 16, 2010 (initiated Aug 25, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 18 cases (total 21,600 pieces) |
| Distribution | Nationwide Distribution: USA, including the states of CA, FL, IL, IN, KS, KY, ND, NE, NH, OH, SC, SD and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960857 | GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR Greiner America, Inc., Aug 30, 1996 |