Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 29, 2020
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.
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Greiner Bio-One North America, Inc. recalled VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE … - a moderate-severity action.
VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE … was recalled by Greiner Bio-One North America, Inc. in January 29, 2020. Reason: The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area. This may le…. Check the official notice for the remedy. Verify recall #Z-0818-2020 with the FDA Devices before acting.
The recall
Greiner Bio-One North America, Inc. issued this moderate-severity FDA Devices recall-The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area. This may le….
- Moderate
- severity level
- Class II
- classification
- January 29, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0818-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0818-2020) was formally reported on January 29, 2020, with the manufacturer initiating the action on November 25, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Greiner Bio-One North America, Inc. is listed as the recalling firm, operating out of Monroe, NC. Federal records list the affected scope as 1,002,000 tubes.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Nationwide distribution in the states of IL, MO, AZ, NC. PA, UT, NY, ME, PR, VA, PA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1,002,000 tubes
Related Recalls
6
3 from same agency
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.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0818-2020 |
| Date reported | January 29, 2020 |
| Date initiated | November 25, 2019 |
| Recalling firm | Greiner Bio-One North America, Inc. |
| Firm location | Monroe, NC |
| Affected scope | 1,002,000 tubes |
| Distribution | Nationwide distribution in the states of IL, MO, AZ, NC. PA, UT, NY, ME, PR, VA, PA |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0818-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Greiner Bio-One North America, Inc.. Units affected: 1,002,000 tubes.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 29, 2020. Severity: Moderate. Recall number: Z-0818-2020.
Where was the recalled product distributed? ▼
Distribution: Nationwide distribution in the states of IL, MO, AZ, NC. PA, UT, NY, ME, PR, VA, PA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0818-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 29, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.