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.
Z-0604-2019
Product summary
- Event
- Event 81421
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60
- Official record key
device-enforcement:Z-0604-2019
Official wording
Reason: 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.
Code information: Lot 413849
Distribution pattern: U.S Distribution to states of: CA, IL, PA, FL, NE, WA, IN, NY, SD and VA,
Derived failure modes
-
Unknown
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.