CLASS II Device recall · Reported 29 Jan 2020 · FDA Enforcement Report
Vacuette Tube Cal Serum Sep Clot Activator recalled
Greiner Bio-One North America is recalling Vacuette Tube Cal Serum Sep Clot Activator, distributed nationwide in the US. The recall was initiated on 25 Nov 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0818-2020
- FDA event ID
- 84536
- Recalling firm
- Greiner Bio-One North America, Monroe, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Nov 2019
- FDA classified
- 17 Jan 2020
- Reported
- 29 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Syringes & Needles
Timeline
| 25 Nov 2019 | Recall initiated by company | |
| 17 Jan 2020 | Classified by FDA | +53 days |
| 29 Jan 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Nationwide distribution in the states of IL, MO, AZ, NC. PA, UT, NY, ME, PR, VA, PA
Nationwide ArizonaIllinoisMaineMissouriNorth CarolinaNew YorkPennsylvaniaPuerto RicoUtahVirginia
Questions about this recall
Why was it 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 lots are affected?
DI: 29120049204476, Lot number B190338E
Where was it sold?
Nationwide distribution in the states of IL, MO, AZ, NC. PA, UT, NY, ME, PR, VA, PA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Greiner Bio-One North America
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|---|---|---|---|---|---|
| Device | CLASS II | Vacuette CAT Serum Separator Clot Activator recalled | Greiner Bio-One North America | Potency & Assay | 28 states |
| Device | CLASS II | Greiner Bio-one Vacuette 9NC Coagulation sodium citrate recalled | Greiner Bio-One North America | Other | Nationwide |
| Device | CLASS II | Vacuette¿ Tube Cat Serum Separator Clot Activator red recalled | Greiner Bio-One North America | Device Malfunction | Nationwide |
| Device | CLASS II | Vacuette Tube FX Sodium Fluoride/Potassium Oxalate recalled | Greiner Bio-One North America | Other | Nationwide |
| Device | CLASS II | greiner bio-one Vacuette Tube K3E K3EDTA recalled | Greiner Bio-One North America | Labeling Errors | Nationwide |
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