PrepStain Syringing Pipettes 240 (Catalog #490517)

FDA device recall Z-1811-2012 · posted 2012-06-15 · Terminated

Recall details

Recalling firm

Tripath Imaging, Inc.

Reason for recall

The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes

Action taken

BD Diagnostics sent a "BD PrepMate Syringing Pipette" letter dated March 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The firm encouraged customers to refer to the Operator's Manual and inspect the centrifuge tubes to verify that the correct amount of sample has been transferred. Customers experiencing this issue were instructed to discard the pipettes and contact BD Diagnostic Technical Support for a replacement. Contact the firm at 1-877-822-7771 for questions regarding this notice.

Root cause

Component design/selection

Status

Terminated

Product code

MKQ

Quantity affected

46,112,784 for all products in Recall Event

Distribution

Worldwide Distribution.

Date initiated

2012-03-22

Date posted

2012-06-15

Date terminated

2012-12-03

Location

Burlington, NC