Recall Z-0736-2016
Instrumentation Laboratory Co. · initiated December 18, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: Lot No. N0455811, Expiration Date 03/31/2017
Reason for recall
This Lot is not meeting labeled on-board instrument stability claims of 5 days.
FDA-determined cause: Device Design
Action taken
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 secondary distributors. For further questions, please call 1(800) 955-9525.
Details
- Recall number
- Z-0736-2016
- Initiated
- December 18, 2015
- Posted by FDA
- February 1, 2016
- Terminated
- August 30, 2017
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- 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.
- Recalling firm
- Instrumentation Laboratory Co., Bedford, MA