FDA recall Z-0477-2019

The Binding Site Group, Ltd. · Class II · device

Product

Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format.

Reason for recall

After running the calibration curve, the recovery of the IgM kit control results decrease demonstrating a reduction in accuracy within the same day; control results may be out of range one day after running the assay calibration curve. Samples have been shown to be similarly affected.

Distribution

U.S.: IL, WV, NE, SD, NY, IN, WA, MD, NJ, PA, NC, AR, FL, VA

Key facts

Status
Terminated
Initiation date
2018-07-25
Report date
2018-11-28
Termination date
2021-04-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Birmingham, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0477-2019