Recalls / —

—#25667

Product

BIOMERIEUX, Thromboplastin Reagent, Simplastin Excel S, 6 ml Diluent, bioMerieux, Inc., Durham, NC 27704

FDA product code

GJS — Test, Time, Prothrombin

Device class

Class 2

Medical specialty

Hematology

510(k) numbers

K882214

Affected lot / code info

Product# 252182- Lot #161553, 161580, 161581 and 161661. Additional Catalog number: 252183, Lot number: 161662. Additional lot numbers recalled 3/19 & 31/2003: Lot #161639, 161664, 161716 and 161717. Recall expanded on 5/30/2003 to include the balance of the lot number produced under previous manufacturing practice. Product Number 252182 (6 ml), Lot number 161506; Prduct Number 252183 (20 ml), Lot Number 161503, 161504, 161554, 161582 and 161640.

Why it was recalled

Vial to vial variability which can result in prolonged clot times.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified by letter via regular mail on December 23, 2002. They were advised to cease using the product, pull affected lot numbers, destroy the material and contact bioMerieux for replacement. Expanded recall 3/18/2003, consignees were notified by letter on March 19th , and March 31, 2003. Consignees were advised to stop using the affected lot numbers, destroy the remaining material in inventory and to contact their local bioMerieux Customer Service representative for replacement.

Recalling firm

Firm

Biomerieux, Inc.

Address

100 Rodolphe Street, Durham, North Carolina 27712

Distribution

Distribution pattern

CA, CO, FL, GA, IA, IN, MN, NC, NJ, TN, WI. Australia, Brazil, Buenos Aires, Canada, Colombia, Hong Kong, Japan, Korea, Mexico, Netherlands, Thailand and the United Kingdom. There were no government accounts involved.

Timeline

Recall initiated

2002-12-23

Posted by FDA

2003-03-06

Terminated

2004-01-21

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #25667. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.