Greiner Bio-One North America, Inc.: Device Recall

Recall Details

Recall Number

Z-2375-2024

Classification

Class II

Product Type

Device

Recalling Firm

Greiner Bio-One North America, Inc.

Status

Ongoing

Date Initiated

05/14/2024

Location

Monroe, NC, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

1,008,000pcs (840 cartons)

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.

Product Description

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

Distribution Pattern

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.

Other Recalls by Greiner Bio-One North America, Inc.

• Class II: Risk 08/19/2025
  Some of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing. This may result in delayed diagnosis, cause a delay in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters.
• Class II: Risk 08/08/2025
  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.

View all recalls by Greiner Bio-One North America, Inc. →