—#26108

Product

Simplasitin Excel, 10 x 6ml, 25200, For Prothrombin Time determinations, bioMerieux, Inc. Durham, NC 27704. The product consists of two vials, a thromboplastin reagent and a diluent ( the vials are mixed together before use).

FDA product code: GJS — Test, Time, Prothrombin
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K864283
Affected lot / code info: Lot numbers: 161402, 161431, 161432, 161477, 161448, 161479, 161507, 161508, 161550, 161551, 161583, 161585, 161595, 161657, 161658. Expanded 3/19/2003 to include lot #161639, 16160 and 1611711. Final expansion of recall initiated 5/30/2003 to include Product Number 252001 (20ml), lot numbers161403, 161480, 161509, 161510, 161552 161586 and 161596.

Why it was recalled

Product is being recalled due to vial to vial variability of clotting time results.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified by a Customer Notification letter sent via regular mail on/about February 4, 2003 with response form attached. An additional cover letter was sent to international affiliates/distributors who were responsible for notifying their customers. Consignees were asked to report the amount of product on hand and to destroy the product. On March 18th the firm expanded the recall. Consignees were notified by letter on March 19th , and March 31, 2003 and 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: Product was distributed nationwide and Brazil, Canada, China, Japan, Korea, Mexico, The Netherlands, Taiwan, Venezuela

Timeline

Recall initiated: 2003-02-04
Posted by FDA: 2003-03-06
Terminated: 2004-01-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #26108. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.