Vacuette 2 ml Lithium Heparin, Collection Tube… recallZ-0623-2011 · Greiner Bio-One North America, Inc. · initiated Aug 25, 2010
Terminated All recalls posted in December 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Greiner Bio-One North America, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0623-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 25, 2010
- Posted by the FDA
- Dec 16, 2010
- Recalling firm
- Greiner Bio-One North America, Inc.
- Quantity
- 18 cases (total 21,600 pieces)
- Product code
- JKA
- FDA submissions
- K960857
- Distribution
- Nationwide Distribution: USA, including the states of CA, FL, IL, IN, KS, KY, ND, NE, NH, OH, SC, SD and WI.
Product description
Vacuette 2 ml Lithium Heparin, Collection Tube, Manufactured by: Greiner-Bio One North America, Inc., 4238 Capital Drive, Monroe, NC. Venous blood collection tubes.
Code information (models, lots, serial numbers)
Item number: 454237, Lot number: B061006
Other devices under the same FDA submission
3 devices cleared under K960857 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Vacuette 456087PGreiner Bio-One GmbH · Tubes, vials, systems, serum separators, blood collection1 recall0 reports
- Vacuette 454008PGreiner Bio-One GmbH · Tubes, vials, systems, serum separators, blood collection1 report
- Vacuette 456287PGreiner Bio-One GmbH · Tubes, vials, systems, serum separators, blood collection1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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