VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring… recallZ-2485-2021 · Greiner Bio-One North America, Inc. · initiated Aug 13, 2021
Terminated
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
Blood collection tubes may experience a clotting issue.
FDA root cause category: Process control
What the company is doing
A distributor and customer letter dated 08/12/2021 was issued to affected consignees. Customers are advised to stop using the recalled product immediately and quarantine affected product within the facility. Customers are asked to complete a Product Disposition form and return to the recalling firm. The firm issued additional letters dated 9/10/2021 on 9/13/2021 via email to distributors and via USPS to other customers informing them of an additional lot number of product that is affected. The letters provide similar instructions as the initial letter.
Recall details
- Recall number
- Z-2485-2021
- Status
- Terminated
- Initiated by the company
- Aug 13, 2021
- Recalling firm
- Greiner Bio-One North America, Inc.
- Quantity
- 962,400 tubes
- Product code
- JKA
- FDA submissions
- K971236
- Distribution
- Distribution was made to AL, AZ, CO, CT, FL, IL, MA, MD, MI, MO, NC, NM, PA, TX, and VA. Foreign distribution was made to Canada.
Product description
VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
Code information (models, lots, serial numbers)
Item Number 456279, Lot B21033DA, exp. 09/08/2022, UDI Case - 39120017571248; UDI Rack - 29120017571241 UPDATE per 9/10/2021 email: Item Number 456279, Lot B21053R8, exp. 11/10/2022, UDI Case -39120017571248; UDI Rack - 29120017571241.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- 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 16, 2026. Text above is shown as published by the FDA.
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