Recalls / —

—#25331

Product

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

FDA product code

JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection

Device class

Class 2

Medical specialty

Clinical Chemistry

510(k) numbers

K940905

Affected lot / code info

Lot #2098765

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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

Recalling firm

Firm

Becton Dickinson & Company

Address

1 Becton Drive, Franklin Lakes, New Jersey 07417

Distribution

Distribution pattern

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

Timeline

Recall initiated

2002-10-16

Posted by FDA

2003-01-16

Terminated

2004-04-15

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #25331. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.