Vacuette 455071PRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 still open.

2 other recalls cover devices cleared under the same FDA submission (BK040066, BK050028, K960858, K983952); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 19, 2025Class IIOpen, Classified

   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.

   Z-0571-2026 · Root cause: Labeling Change Control · Recall details · FDA record ↗

2. May 14, 2024Class IIOpen, Classified

   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.

   Z-2375-2024 · Root cause: Employee error · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under BK040066, BK050028, K960858, K983952. One submission often covers many models, so check the product and lot details in each record.

• Z-0818-2020 · Nov 25, 2019 · Terminated
  VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood
• Z-0086-06 · Jul 28, 2005 · Terminated
  Serum Blood Collection Tubes