Recall Z-0736-2016 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
Instrumentation Laboratory Co.
HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate
| Date | Feb 1, 2016 (initiated Dec 18, 2015) |
| Status | Terminated |
| Reason | This Lot is not meeting labeled on-board instrument stability claims of 5 days. |
| Root cause | Device Design |
| Action | Instrumentation Laboratory Co. sent an " Urgent Medical Device Removal" letter dated December 2015, was sent on December 18, 2015. via USPS to US and Canadian customers. The notification requires US and Canadian customers to respond using a Mandatory Response Tracking Form. A Field Safety Notice was e-mailed on December 18, 2015, to the affected IL affiliates, notifying them of the product lot removal due to a stability issue and requesting them to translate the Field Safety Notice, to notify their Competent Authorities and to provide the notification to their affected customer base and sec |
| Quantity | Domestic: 108 kits, Foreign: 197 kits |
| Distribution | Worldwide Distribution - US Distribution and to the countries of : Canada, Argentina, Austria, Belgium, Brazil, China, Czech Republic, France, Germany, Hong Kong, Italy, Lithuania, Panama, Poland, Russia, Saudi Arabia, United Kingdom, and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981200 | IL TEST PLASMINOGEN Instrumentation Laboratory CO, May 26, 1998 |