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Terminated

MDA Simplastin L, Product number 252555, 10 vials, 40 ml ea (400 test each), bioMerieux Inc., Box 15969 Durham, North Carolina 27704-0969.

FDA Recall Z-1239-03 · Posted 2003-10-15

Recalling FirmbioMerieux
Recall StatusTerminated
Product CodeGJS
Date Initiated2003-07-31
Date Terminated2004-05-18
Product Quantity857 units

Reason for Recall

Complaints of prolonged clot times.

Firm Action

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.

Root Cause

Other

Distribution Pattern

The product was distributed to hospitals and distributors located nationwide, Brazil, Canada, China, and Japan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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