PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported September 29, 2021

Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged

Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.

Recall #
Z-2507-2021
Affected scope
956,400
Initiated
August 20, 2021
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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Greiner Bio-One North America, Inc. recalled Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-wh… - a moderate-severity action.

Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-wh… was recalled by Greiner Bio-One North America, Inc. in September 29, 2021. Reason: Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.. Check the official notice for the remedy. Verify recall #Z-2507-2021 with the FDA Devices before acting.

The recall

Greiner Bio-One North America, Inc. issued this moderate-severity FDA Devices recall-Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum..

Moderate
severity level
956K units
affected scope
Class II
classification
September 29, 2021
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2507-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-2507-2021) was formally reported on September 29, 2021, with the manufacturer initiating the action on August 20, 2021. 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 956,400, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum. Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MD, ME, MO, MT, NC, NE, NM, NV, NY, OH, OR, PA, TX, VA, WA and Puerto Rico.. 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, 6 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 - 40,409 medical devices recalls on record

-1,00001,0002,0003,0004,0005,000 20052008201120142017202020232026 1,243

Where this recall sits in the database

Severity2366872097High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 100,165 recalls in the database, 23,668 are high severity, 72,097 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

956,400

Related Recalls

6

6 from same agency

Product description

Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged

Reason for recall

Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-2507-2021
Date reported September 29, 2021
Date initiated August 20, 2021
Recalling firm Greiner Bio-One North America, Inc.
Firm location Monroe, NC
Affected scope 956,400
Distribution US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MD, ME, MO, MT, NC, NE, NM, NV, NY, OH, OR, PA, TX, VA, WA and Puerto Rico.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

956,400 units affected - multi-state distribution scale.

Regional (<10K units) -
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) ✓ This recall
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-2507-2021) 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?
Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged. Recalled by Greiner Bio-One North America, Inc.. Units affected: 956,400.
Why was this product recalled?
Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 29, 2021. Severity: Moderate. Recall number: Z-2507-2021.
Where was the recalled product distributed?
Distribution: US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MD, ME, MO, MT, NC, NE, NM, NV, NY, OH, OR, PA, TX, VA, WA and Puerto Rico..
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-2507-2021) 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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Data Sources

Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported September 29, 2021.

  • Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. 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 June 2026.