Z-2375-2024Class II

VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged

Name: Z-2375-2024 VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
Creator: Greiner Bio-One North America, Inc.
Published: 2024-05-14
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2024-05-14 / Open, Classified / root cause: manufacturing process

FDA source

Greiner Bio-One North America, Inc. began a recall of VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged on 2024-05-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2375-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-14
Posted: 2024-07-17
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
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected]. 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 in commerce: 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.
Product codes and lots: Item Number: 455071P; UDI Case label: 39120017573068; UDI Rack label: 29120017573061; Lot Number: B24013MV

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2375-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2375-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-17

Product code JKA

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)