Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Serum Blood Collection Tubes

FDA Recall Z-0086-06 · Posted 2005-10-22

Recalling FirmGreiner VACUETTE North America
Recall StatusTerminated
Product CodeJKA
Date Initiated2005-07-28
Date Terminated2005-11-16
Product Quantity1623 cases (1,947,600 pieces)

Reason for Recall

Serum Blood Collection tubes found with excess of Blood Clot Accelerator (BCA) solution.

Firm Action

Consignees were notified by letter on 07/28/2005.

Root Cause

Other

Distribution Pattern

Nationwide, Chile, Costa Rica, Ecuador, El Salvador, Nicaragua and Uruguay.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K960858GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATORGreiner America, Inc. · 1996-08-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑