Severity
Moderate
FDA Devices recall · Reported July 24, 2024
The firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. The failure of the device would likel…
Greiner Bio-One North America, Inc. recalled VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-r… - a moderate-severity action.
VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-r… was recalled by Greiner Bio-One North America, Inc. in July 24, 2024. Reason: The firm received reports that some blood collection tubes have experienced issues with clotting and poor sep…. Check the official notice for the remedy. Verify recall #Z-2375-2024 with the FDA Devices before acting.
The recall
Greiner Bio-One North America, Inc. issued this moderate-severity FDA Devices recall-The firm received reports that some blood collection tubes have experienced issues with clotting and poor sep….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2375-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2375-2024) was formally reported on July 24, 2024, with the manufacturer initiating the action on May 14, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Greiner Bio-One North America, Inc. is listed as the recalling firm, operating out of Monroe, NC. Federal records list the affected scope as 1,008,000pcs (840 cartons).
The documented reason for this recall is: The firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. The failure of the device would likely require sample recollection which coul… Distribution data in the federal record shows the product reached: Nationwide Distribution to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV and WY.. 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.
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.
Severity
Moderate
Affected scope
1,008,000pcs (840 cartons)
Related Recalls
6
3 from same agency
VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
The firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. The failure of the device would likely require sample recollection which could result in a delay of treatment.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2375-2024 |
| Date reported | July 24, 2024 |
| Date initiated | May 14, 2024 |
| Recalling firm | Greiner Bio-One North America, Inc. |
| Firm location | Monroe, NC |
| Affected scope | 1,008,000pcs (840 cartons) |
| Distribution | Nationwide Distribution to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV and WY. |
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.
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.
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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 July 24, 2024. 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.