FDA Medical Device Recalls (openFDA)
Greiner Bio-One North America, Inc.: VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
- Recall number
- Z-2375-2024
- Recalling firm
- Greiner Bio-One North America, Inc.
- Product
- VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
- Status
- Open, Classified
- Initiated
- 2024-05-14
- Posted
- 2024-07-17
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Employee error
- Action
- Customers were notified of the recall beginning on 05/14/2024 via emailed "Urgent Product Recall" letter. Distributors were also notified of the recall on 05/14/2024 via UPS, email and phone. The customers and Distributors were instructed to 1. Stop using the product (concerned Item/Lot) immediately and isolate defective products in the facility; 2. Assess the risks and consequences of the use of this defective product in accordance with procedures and take appropriate action; 3. Complete the attached Product Disposition Site Confirmation form and fax to Greiner Bio-One North America, Inc. at 877-217-7927 or email to recalls.us@gbo.com. This form is to confirm that you have discarded/destroyed all products from this Item/Lot. Greiner will replace the product upon receipt of your completed form. Greiner will contact the distributor for the return of the product after receiving the attached Product Disposition Site Confirmation form. They will also use this information to issue a credit. If you have additional questions, please call Greiner Technical Service at 704-220-1664.
- Quantity
- 1,008,000pcs (840 cartons)
- Distribution
- 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.
- Lot, serial or model codes
- Item Number: 455071P; UDI Case label: 39120017573068; UDI Rack label: 29120017573061; Lot Number: B24013MV
- 510(k) numbers
- ["K081929","K960858","K983952"]
- 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