bioMerieux Simplastin L, Prothrombin Time test, 10 vials (20 ml each), Product Number 259553, bioMerieux, Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Simplastin L, Prothrombin Time test, 10 vials (20 ml each), Product Number 259553, bioMerieux,
Brand
bioMerieux
Lot Codes / Batch Numbers
Product #259553, Lot #161642, 161643 and 161690.
Products Sold
Product #259553, Lot #161642, 161643 and 161690.
bioMerieux is recalling Simplastin L, Prothrombin Time test, 10 vials (20 ml each), Product Number 259553, bioMerieux, due to Complaints of prolonged clot times.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Complaints of prolonged clot times.
Recommended Action
Per FDA guidance
Consignees were notified via letter on July 31, 2003. The were advised to check remaining inventory and destroy any remaining material of the affected lot numbers. A Customer Response form was attached.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026