VACUETTE, 2 ml Lithium Heparin Venous Blood Collection… recallZ-0215-2009 · Greiner Bio-One North America, Inc. · initiated Jul 29, 2008
Terminated All recalls posted in November 2008
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
Labeling Error: Incorrect tube label reads "Z Serum Clot Activator" instead of "LH Lithium Heparin" tube. All other information on the tube label including color coding of tube was correct. Case and rack label information showed the correct information with 2 ml Lithium Heparin.
FDA root cause category: Labeling mix-ups
What the company is doing
Consignees were notified by letter on 07/29/2008. Notification letters to distributors instructed them to stop distribution of the product and destroy all affected lots of the product. In addition, notification letters addressed to users instructed them to destroy and discard all products from the item and affected lots. The "Product Disposition Form" must be completed by the consignee and returned to Greiner Bio-One North America, Inc. For questions or additional information, contact Greiner Bio-One North America, Inc. at 704-261-7800.
Recall details
- Recall number
- Z-0215-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 29, 2008
- Posted by the FDA
- Nov 7, 2008
- Recalling firm
- Greiner Bio-One North America, Inc.
- Quantity
- 33 cases (39,600 pieces)
- Product code
- JKA
- FDA submissions
- K960857
- Distribution
- Worldwide including USA (states of AK, AL, AR, CA, CO, DE, GA, ID, IL, IN, KS, LA, MA, MI, MO, MS, NC, ND, NE, NH, NY, OH, OK, OR, PA, RI, SC, SD, TX, VA, VT, WA, and WI) and country of Canada.
Product description
VACUETTE, 2 ml Lithium Heparin Venous Blood Collection Tubes. Reference #454237, 13x75 green cap-white ring, 24 racks of 50 pcs (1200 pcs in total, non ridged, Sterile). Manufactured by: Greiner bio-one NA, Inc., 4238 Capital Drive, Monroe, NC 28110. The Greiner Vacuette blood collection tube with lithium heparin and gel separator is an evacuated blood collection device containing lithium heparin, an anticoagulant additive, and an inert polymeric barrier material. The product is intended for use in holding and separating blood plasma from the cellular components of blood.
Code information (models, lots, serial numbers)
Lot # B120703.
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.
How recalls are matched to devices · Editorial policy · Report an error on this page