[pending] Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 4
Pending LLM rewrite. Source: FDA_DEVICE Z-0571-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- 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)
- Manufacturer
- Greiner Bio-One North America, Inc.
- Category
- Medical Device — Devices
Distribution
Distributed in 28 states:
- 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
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