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
This recall has been terminated (originally issued February 1, 2016).
- Company
- Instrumentation Laboratory Co.
- Recall Initiated
- December 18, 2015
- Posted
- February 1, 2016
- Terminated
- August 30, 2017
- Recall Number
- Z-0736-2016
- Quantity
- Domestic: 108 kits, Foreign: 197 kits
- Firm Location
- Bedford, MA
- Official Source
- View on FDA website ↗
Reason for Recall
This Lot is not meeting labeled on-board instrument stability claims of 5 days.
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.
Lot / Code Info
Lot No. N0455811, Expiration Date 03/31/2017
Root 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.