BIOMERIEUX, Thromboplastin Reagent, Simplastin Excel S, 6 ml Diluent, bioMerieux, Inc., Durham, NC 27704
FDA Recall Z-0628-03 · Posted 2003-03-06
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Recalling FirmBiomerieux, Inc.
Recall StatusTerminated
Product CodeGJS
Date Initiated2002-12-23
Date Terminated2004-01-21
Product Quantity4276 kits of lot #161553, 4275 kits of lot #161580, 4279 kits of lot #161581 and 4300 kits of lot 161661. Additional 2,280 kits of lot 161662.
Reason for Recall
Vial to vial variability which can result in prolonged clot times.
Firm Action
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.
Root Cause
Other
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.
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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