VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF… recallZ-0818-2020 · Greiner Bio-One North America, Inc. · initiated Nov 25, 2019
Class II 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
The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area. This may lead to a vacuum loss and tubes not filling up to the proper volume.
FDA root cause category: Process control
What the company is doing
The firm initiated the recall by email on 11/25/2019. The letter explained the problem and requested the consignees cease distribution and provide a list of their customers for Greiner to contact. The firm is seeking return or on site destruction of the affected product.
Recall details
- Recall number
- Z-0818-2020
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 25, 2019
- Recalling firm
- Greiner Bio-One North America, Inc.
- Quantity
- 1,002,000 tubes
- Product code
- JKA
- FDA submissions
- K983952
- Distribution
- Nationwide distribution in the states of IL, MO, AZ, NC. PA, UT, NY, ME, PR, VA, PA
Product description
VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or whole blood in the clinical laboratory.
Code information (models, lots, serial numbers)
DI: 29120049204476, Lot number B190338E
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Vacuette 454067PGreiner Bio-One GmbH · Tubes, vials, systems, serum separators, blood collection1 recall0 reports
Other devices under the same FDA submission
2 devices cleared under K983952 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Vacuette 455071PGreiner Bio-One GmbH · Tubes, vials, systems, serum separators, blood collection2 recalls0 reports
- Vacuette 456073PGreiner 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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