Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot… — Class II medical device recall Z-0571-2026
Ongoing recall by Greiner Bio-One North America, Inc., reported 2025-11-26, distributed in AL, AR, CA, CO, CT, FL, GA, IA…. Some of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which
| Recall number | Z-0571-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Greiner Bio-One North America, Inc., Monroe, NC, United States |
| Recall initiated | 2025-08-19 |
| Classified | 2025-11-19 |
| Reported by FDA | 2025-11-26 |
| Distributed | 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, WY |
| Quantity | 1,980,000 |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 29120017573061 |
| Lot numbers | B250437N |
| Serial numbers | 455071P |
| Model numbers | 455071P |
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)
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0571-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.