Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
Reported: February 10, 2021 Initiated: November 18, 2020 #Z-0943-2021
Product Description
Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
Reason for Recall
Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned values.
Details
- Recalling Firm
- The Binding Site Group, Ltd.
- Units Affected
- 213 kits in the U.S.
- Distribution
- U.S.: CO, FL, IA, MA, NC, NJ, NY, OH, SD, and UT. O.U.S.: Not provided
- Location
- Birmingham
Frequently Asked Questions
What product was recalled? ▼
Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A. Recalled by The Binding Site Group, Ltd.. Units affected: 213 kits in the U.S..
Why was this product recalled? ▼
Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned values.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 10, 2021. Severity: Moderate. Recall number: Z-0943-2021.
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