U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Some of the cards were stamped with an incorrect card code causing the system to read and report the cards incorrectly.
조치
The firm issued recall letters dated 4/20/04 via certified mail requesting remaining inventories be destroyed and explaining the method which the customer can use to confirm the cards were not misreported.
Distribution was made to medical centers and laboratories nationwide, which include government and military consignees. Foreign distribution was made to bioMerieux subsidiaries in Switzerland, Portugal, and the Philippines.
제품 설명
VITEK GPS-107Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC.