Recall Z-1050-2017
The Binding Site Group, Ltd. · initiated November 28, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.
Codes / lots: Lot #323278, 327963
Reason for recall
Calibration curve activity has increased over time in the kit lots listed.
FDA-determined cause: Unknown/Undetermined by firm
Action taken
Customer notification letters were sent 11/28/12. Customers were asked to discontinue using the listed kit lots. Discard any unused or partially-used kits of these lots. Let The Binding Site know how many replacement kits are required.
Details
- Recall number
- Z-1050-2017
- Initiated
- November 28, 2012
- Posted by FDA
- January 19, 2017
- Terminated
- March 3, 2017
- Product code
- DEH – Lambda, Antigen, Antiserum, Control
- Quantity
- 1,002
- Distribution
- U.S. distribution to the following; CA, TX, HI, GA, PA, UT, NY, OK, ID, MA, AZ. Foreign distribution to the following; Australia, Bulgaria, Denmark, Hong Kong, Ireland, Israel, Japan, New Zealand, Taiwan, Belgium, France, Italy, Spain.
- Recalling firm
- The Binding Site Group, Ltd., Birmingham