Skip to content

VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100 recallZ-2375-2024 · Greiner Bio-One North America, Inc. · initiated May 14, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Greiner Bio-One North America, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Employee error

What the company is doing

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.

Recall details

Recall number
Z-2375-2024
Status
Open, Classified
Initiated by the company
May 14, 2024
Posted by the FDA
Jul 17, 2024
Recalling firm
Greiner Bio-One North America, Inc.
Quantity
1,008,000pcs (840 cartons)
Product code
JKA
FDA submissions
K081929, K960858, K983952
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 description

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

Code information (models, lots, serial numbers)

Item Number: 455071P; UDI Case label: 39120017573068; UDI Rack label: 29120017573061; Lot Number: B24013MV

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

3 devices cleared under K081929, K960858, K983952 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page