Recall Z-0197-05 ยท NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Tosoh Bioscience, Inc.
Tosoh brand AIA-PACK CA 19-9 Test Cup Set used in TOSOH AIA Immunoassay Analyzers, A pack contains 10 trays of 20 test cups, Catalog #: 020271, For IN VITRO Diagnostic Use, The product is manufactured by TOSOH CORPORATION, TOKYO, JAPAN
| Date | Nov 16, 2004 (initiated Sep 23, 2004) |
| Status | Terminated |
| Reason | On 10/30/04, the firm initiated the recall and its notification was via letters requesting return of affected devices. |
| Root cause | Other |
| Action | On 10/30/04, the firm initiated the recall and its notification was via letters requesting return of affected device. |
| Quantity | 133 boxes |
| Distribution | The firm distributed product to 10 consumers and 1 distributor, to locations in CA, CO, FL, MD, NY, OH, SC and TX. No federal government agency sales/distribution centers or foreign countries received the product. The last product distributed was on 6/15/2004. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.