Recalls / —

—#41886

Product

VeriCal Calibrator Set

FDA product code

JPA — System, Multipurpose For In Vitro Coagulation Studies

Device class

Class 2

Medical specialty

Hematology

Affected lot / code info

Lots 161813, 161907, 161908, 161909

Why it was recalled

The product is being recalled due to mis-assignment of ISI values associated with VeriCal use.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified on/about 08/31/2005.

Recalling firm

Firm

BIOMERIEUX, INC.

Address

100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

Distribution pattern

Nationwide

Timeline

Recall initiated

2005-08-19

Posted by FDA

2005-10-22

Terminated

2006-10-16

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #41886. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.