CLASS II ONGOING Device recall · Reported 24 Jul 2024 · FDA Enforcement Report
Vacuette¿ Tube Cat Serum Separator Clot Activator red recalled
Greiner Bio-One North America is recalling Vacuette¿ Tube Cat Serum Separator Clot Activator red cap-yellow ring, non-ridged, distributed nationwide in the US. The recall was initiated on 14 May 2024 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-2375-2024
- FDA event ID
- 94817
- Recalling firm
- Greiner Bio-One North America, Monroe, NC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 May 2024
- FDA classified
- 17 Jul 2024
- Reported
- 24 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 14 May 2024 | Recall initiated by company | |
| 17 Jul 2024 | Classified by FDA | +64 days |
| 24 Jul 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichigan
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Item Number: 455071P; UDI Case label: 39120017573068; UDI Rack label: 29120017573061; Lot Number: B24013MV
Where was it sold?
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.
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
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 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 |
| Device | CLASS II | greiner bio-one Vacuette Tube LH Lithium Heparin Sep recalled | Greiner Bio-One North America | Other | 10 states |
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