Z-1089-2017 Class III Terminated
FDA device recall Z-1089-2017 was initiated by The Binding Site Group, Ltd. on December 23, 2016 and is designated Class III. Reason for recall: A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided… The recall status is terminated (terminated May 3, 2017). Affected quantity: 9 users.
Recall Details
- Product Type
- Devices
- Report Date
- February 1, 2017
- Initiation Date
- December 23, 2016
- Termination Date
- May 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 users
Product Description
Optilite IgG4 Kit Product Code: LK009.OPT.A
Reason for Recall
A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert
Distribution Pattern
U.S. distribution to the following; FL, TX, PA, CA, MA, WA, MI, CT. No foreign distribution.
Code Information
Lot #401413