CLASS II Device recall · Reported 24 May 2023 · FDA Enforcement Report
greiner bio-one Vacuette Tube K3E K3EDTA recalled
Greiner Bio-One North America is recalling greiner bio-one Vacuette Tube K3E K3EDTA, pink cap-black ring, non-ridged, 24 racks of in, distributed nationwide in the US. The recall was initiated on 31 Mar 2023 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-1583-2023
- FDA event ID
- 92025
- Recalling firm
- Greiner Bio-One North America, Monroe, NC
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 31 Mar 2023
- FDA classified
- 12 May 2023
- Reported
- 24 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 31 Mar 2023 | Recall initiated by company | |
| 12 May 2023 | Classified by FDA | +42 days |
| 24 May 2023 | 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
Some of the tubes may be incorrectly labeled.
Product as listed by the FDA
greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003
Where it was distributed
US Nationwide distribution in the states of WI and GA.
Questions about this recall
Is greiner bio-one Vacuette Tube K3E K3EDTA, pink cap-black ring, non-ridged, 24 racks of in recalled?
Yes. Greiner Bio-One North America recalled greiner bio-one Vacuette Tube K3E K3EDTA, pink cap-black ring, non-ridged, 24 racks of in on 31 Mar 2023. The recall is Class II and its status is Completed. Recall number Z-1583-2023.
Why was it recalled?
Some of the tubes may be incorrectly labeled.
Which lots are affected?
Lot #B220533J, Exp. 2023-10-31, UDI Case label (01)39120017576496(17)231031(10)B220533J, UDI Rack label 29120017576499(17)231031(10)B220533J.
Where was it sold?
US Nationwide distribution in the states of WI and GA.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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