Recall Z-0417-2015 ยท JZH Factor B, Antigen, Antiserum, Control
Diagnostic Hybrids Inc
MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
| Date | Sep 3, 2015 (initiated Oct 16, 2014) |
| Status | Terminated |
| Reason | Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented. |
| Root cause | Device Design |
| Action | Quidel sent an Urgent Medical Device Recall letter dated October 16, 2014, to all consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately review their inventory and determine if they have of the affected product. If so, they should remove it from their inventory and destroy it immediately by discarding it into their normal biomedical waste stream. Complete the enclosed Certificate of Destruction. Upon receipt of the Certificate of Destruction, Quidel, will then schedule their shipment of replacement |
| Quantity | 171 |
| Distribution | Worldwide Distribution - USA, including AL, CO, CT, FL, KY, MN, NC, NV, OH, PA, and WA; and, the countries of Canada, China, India, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.