Recall Z-2071-2018 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
Tosoh Bioscience Inc
ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker
| Date | Mar 5, 2018 |
| Status | Terminated |
| Reason | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. |
| Root cause | Device Design |
| Action | The firm TOSOH Bioscience Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter dated March 23, 2018 to affected customers. The letter described the product, problem and action to be taken. The customers were instructed to do the following: *Based on our revised labeling, the assays identified in Table 1 should not be used for patients who are being treated with Asfotase Alfa. " For patients that are being treated with Asfotase Alfa, use an alternative test method that does not utilize alkaline phosphatase technology. " Inform all medical professionals that assays utilizing alkaline phosphata |
| Quantity | 2549 |
| Distribution | Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K913298 | AIA-PACK CK-MB Tosoh Corp., Sep 27, 1991 |