Vacuette 2 ml Lithium Heparin, Collection Tube, Manufactured by: Greiner-Bio One North America, Inc., 4238 Capital Drive
FDA device recall Z-0623-2011 · posted 2010-12-16 · Terminated
Recall details
- Recalling firm
- Greiner Bio-One North America, Inc.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JKA
- Quantity affected
- 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.
- Date initiated
- 2010-08-25
- Date posted
- 2010-12-16
- Date terminated
- 2012-05-15
- Location
- Monroe, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR (K960857) | Greiner America, Inc. | 1996-08-30 |