Z-1583-2023Class II

greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs...

Name: Z-1583-2023 greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs...
Creator: Greiner Bio-One North America, Inc.
Published: 2023-03-31
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2023-03-31 / Completed / root cause: labeling and UDI

FDA source

Greiner Bio-One North America, Inc. began a recall of 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 on 2023-03-31. FDA classified it as Class II and gives the reason as "Some of the tubes may be incorrectly labeled". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1583-2023
Classification: Class II
Status: Completed
Initiated: 2023-03-31
Posted: 2023-05-12
Recalling firm: Greiner Bio-One North America, Inc.
Product: 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
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Some of the tubes may be incorrectly labeled.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: The recalling firm issued a letter dated 3/30/2023 on 3/31/2023 via email to their sole customer. The letter provided the reason for recall, contained detailed information regarding the complaint, provided photographs of the product which included incorrect tube labels and correct tube labels, investigation results, health risk analysis, and actions to be taken. Those actions included to discontinue use of the product immediately and isolate it, assess the risks and consequences of the use of the defective product in accordance with the customer's procedures and take appropriate action, and complete the attached Product Disposition Site Confirmation. The customer is to record the amount of product they have destroyed on the form and return it via FAX or email. It also instructs that if the customer has distributed this product elsewhere, they are requested to provide the recalling firm with the contact information for follow-up.
Quantity in commerce: 36,000 pieces (30 full cases)
Distribution: US Nationwide distribution in the states of WI and GA.
Product codes and lots: Lot #B220533J, Exp. 2023-10-31, UDI Case label (01)39120017576496(17)231031(10)B220533J, UDI Rack label 29120017576499(17)231031(10)B220533J.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1583-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1583-2023	Class II	Completed	Voluntary: Firm initiated	2023-05-24	2023-05-12

Product code JKA

K960860Class IIGreiner Vacuette Blood Collection Tube E/edta K3Greiner America, Inc. / cleared 1996-09-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)