greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink… recallZ-1583-2023 · Greiner Bio-One North America, Inc. · initiated Mar 31, 2023
Completed
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
Some of the tubes may be incorrectly labeled.
FDA root cause category: Labeling Change Control
What the company is doing
The recalling firm issued a letter dated 3/30/2023 on 3/31/2023 via email to their sole customer. The letter provided the reason for recall, contained detailed information regarding the complaint, provided photographs of the product which included incorrect tube labels and correct tube labels, investigation results, health risk analysis, and actions to be taken. Those actions included to discontinue use of the product immediately and isolate it, assess the risks and consequences of the use of the defective product in accordance with the customer's procedures and take appropriate action, and complete the attached Product Disposition Site Confirmation. The customer is to record the amount of product they have destroyed on the form and return it via FAX or email. It also instructs that if the customer has distributed this product elsewhere, they are requested to provide the recalling firm with the contact information for follow-up.
Recall details
- Recall number
- Z-1583-2023
- Status
- Completed
- Initiated by the company
- Mar 31, 2023
- Posted by the FDA
- May 12, 2023
- Recalling firm
- Greiner Bio-One North America, Inc.
- Quantity
- 36,000 pieces (30 full cases)
- Product code
- JKA
- FDA submissions
- K960860
- Distribution
- US Nationwide distribution in the states of WI and GA.
Product description
greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003
Code information (models, lots, serial numbers)
Lot #B220533J, Exp. 2023-10-31, UDI Case label (01)39120017576496(17)231031(10)B220533J, UDI Rack label 29120017576499(17)231031(10)B220533J.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Vacuette 456003Greiner Bio-One GmbH · Blood/plasma collection device for DNA testing1 recall0 reports
Other devices under the same FDA submission
1 device cleared under K960860 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Vacuette 454021Greiner Bio-One GmbH · Blood/plasma collection device for DNA testing1 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 16, 2026. Text above is shown as published by the FDA.
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