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Terminated

Microtainer Brand Tube with EDTA (K2), Catalog Number 365974.

FDA Recall Z-0447-03 · Posted 2003-01-16

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeJKA
Date Initiated2002-10-16
Date Terminated2004-04-15
Product Quantity141600

Reason for Recall

Insufficient amount of EDTA found within the tube causing clotting and erroneous platelet counts.

Firm Action

Becton Dickinson contacted their Distributors and customers with return instructions via certified mail on or about Oct. 16, 2002.

Root Cause

Other

Distribution Pattern

The firm distributed this product nationwide to wholesalers and direct customers.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K940905MICROTAINER BRAND TUBE WITH EDTA(K2)Bd Becton Dickinson Vacutainer Systems Preanalytic · 1994-08-02

Official Source

View FDA Recall →

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

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