Vacuette 2 ml Lithium Heparin, Collection Tube, Manufactured by: Greiner-Bio One North America, Inc., 4238 Capital Drive, Monroe, NC. Venous blood collection tubes.
FDA Recall Z-0623-2011 · Posted 2010-12-16
Recalling FirmGreiner Bio-One North America, Inc.
Recall StatusTerminated
Product CodeJKA
Date Initiated2010-08-25
Date Terminated2012-05-15
Product Quantity18 cases (total 21,600 pieces)
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide Distribution: USA, including the states of CA, FL, IL, IN, KS, KY, ND, NE, NH, OH, SC, SD and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.