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Recall Observatory FDA recall evidence

Device product

Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)

Z-0571-2026

August 19, 2025

Class II

Product summary

Firm
Greiner Bio-One North America, Inc.
Event
Event 97499
Status
Ongoing
Classification
Class II
Quantity
1,980,000
Official record key
device-enforcement:Z-0571-2026

Official wording

Reason: 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.

Code information: Lot Code: Lot/Serial Numbers: Item# 455071P Lot# B250437N UDI-DI code: 29120017573061

Distribution pattern: U.S.: AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, NJ, NY, OH, OK, PA, TN, TX, UT, VA and WY. O.U.S.: None

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.