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Recall Observatory FDA recall evidence

Device product

Optilite IgG4 Kit Product Code: LK009.OPT.A

Z-1089-2017

December 23, 2016

Class III

Product summary

Firm
The Binding Site Group, Ltd.
Event
Event 76131
Status
Terminated
Classification
Class III
Quantity
9 users
Official record key
device-enforcement:Z-1089-2017

Official wording

Reason: 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

Code information: Lot #401413

Distribution pattern: U.S. distribution to the following; FL, TX, PA, CA, MA, WA, MI, CT. No foreign distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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