FDA-Device2018-12-19Class II
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.
The Binding Site Group, Ltd.
Hazard
Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the specified ranges.
Sold states
U.S Distribution to states of: CA, IL, PA, FL, NE, WA, IN, NY, SD and VA,
Affected count
60
Manufactured in
8 Calthorpe Road, N/A, Birmingham, N/A, United Kingdom
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0604-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief