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 Recall Z-0629-03 · Posted 2003-03-06
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Recalling FirmBiomerieux, Inc.
Recall StatusTerminated
Product CodeGJS
Date Initiated2003-02-04
Date Terminated2004-01-21
Product Quantity62,435 units, Expanded Lot #161659, 3525 boxes; 161660, 1489 boxes; 161711, 3990 boxes
Reason for Recall
Product is being recalled due to vial to vial variability of clotting time results.
Firm Action
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.
Root Cause
Other
Distribution Pattern
Product was distributed nationwide and Brazil, Canada, China, Japan, Korea, Mexico, The Netherlands, Taiwan, Venezuela
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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