Greiner bio-one, 4ml K2E EDTA K2 Vacuette tube. Used for… recallZ-0184-2012 · Greiner Bio-One North America, Inc. · initiated Aug 12, 2011
Terminated All recalls posted in November 2011
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
Vacuette 4ml EDTA DK2 tubes have been reported for short fills to no fills.
FDA root cause category: Process control
What the company is doing
Consignees were notified by Greiner bio-one letter on August 11, 2011. They were instructed to: Stop distributing the material, complete the product Disposition form attach and to fax it to Greiner bio-one and to destroy or return any of the affected products for replacement or credit. Distributors were asked to provide a list of their customers that have received the item, preferably in an Excel file, so that they could be notified of the recall.
Recall details
- Recall number
- Z-0184-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 12, 2011
- Posted by the FDA
- Nov 14, 2011
- Recalling firm
- Greiner Bio-One North America, Inc.
- Quantity
- 504,000 pieces
- Product code
- JKA
- FDA submissions
- K971236
- Distribution
- Nationwide.
Product description
Greiner bio-one, 4ml K2E EDTA K2 Vacuette tube. Used for venous blood collection. Item number 454209.
Code information (models, lots, serial numbers)
Item #454209, Lot #B051111.
Other devices under the same FDA submission
1 device cleared under K971236 — 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 456279Greiner Bio-One GmbH · Tubes, vials, systems, serum separators, blood collection1 recall0 reports
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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