FDA Medical Device Recalls (openFDA)
Greiner Bio-One North America, Inc.: Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
- Recall number
- Z-0408-2026
- Recalling firm
- Greiner Bio-One North America, Inc.
- Product
- Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
- Status
- Open, Classified
- Initiated
- 2025-08-08
- Posted
- 2025-10-28
- Terminated
- not on file
- Reason
- Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections.
- Root cause
- Under Investigation by firm
- Action
- Greiner issued an Urgent Product Recall notice to its consignees on 08/19/2025 via email and fax. The notice explained the issue and requested the following: "Immediate Actions Required 1. Stop Distribution & Isolate Inventory Immediately cease distribution of the affected lot and segregate all remaining units. 2. Select ONE of the following notification options: A. Customer Notification by Greiner Bio-One o Complete the attached Product Disposition Site Confirmation form. o Email the form to recalls.us@gbo.com or fax to 877-217-7927. o Provide an Excel list of all customers including, if applicable, subdistributors who received the affected product, containing: . Facility name and address (city, state, ZIP) . Contact name, email, and phone number for Clinical/Laboratory Director or Supply Chain . Date(s) and quantity shipped o Greiner will handle direct customer notification and coordinate product return/credit. B. Customer Notification by Distributor o Use the customer letter provided by Greiner Bio-One. o Contact all customers who received the affected lot, including any sub-distributors. o Conduct follow-up with non-responders and document effectiveness checks per FDA guidance: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/industryguidance-recalls" For questions regarding this recall, please contact: Greiner Bio-One Technical Service, Phone: 800-515-8112, Fax: 877-217-7927, Email: recalls.us@gbo.com
- Quantity
- 504,000
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI-DI: 29120017574488(Rack), 39120017574485(Case). Lot: B250139Q, Expiration: 01/09/2026
- 510(k) numbers
- ["K971221"]
- PMA numbers
- not on file
- Product code
- GIM
- 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