FDA Medical Device Recalls (openFDA)
Greiner Bio-One North America, Inc.: 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
- Recall number
- Z-1583-2023
- 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
- Status
- Completed
- Initiated
- 2023-03-31
- Posted
- 2023-05-12
- Terminated
- not on file
- Reason
- Some of the tubes may be incorrectly labeled.
- 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
- 36,000 pieces (30 full cases)
- Distribution
- US Nationwide distribution in the states of WI and GA.
- Lot, serial or model codes
- Lot #B220533J, Exp. 2023-10-31, UDI Case label (01)39120017576496(17)231031(10)B220533J, UDI Rack label 29120017576499(17)231031(10)B220533J.
- 510(k) numbers
- ["K960860"]
- PMA numbers
- not on file
- Product code
- JKA
- Firm FEI
- 3001451379
- Firm city
- Monroe
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28