Z-0604-2019 Class II Terminated
FDA device recall Z-0604-2019 was initiated by The Binding Site Group, Ltd. on November 6, 2018 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated April 27, 2021). Affected quantity: 60.
Recall Details
- Product Type
- Devices
- Report Date
- December 19, 2018
- Initiation Date
- November 6, 2018
- Termination Date
- April 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60
Product Description
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
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.
Distribution Pattern
U.S Distribution to states of: CA, IL, PA, FL, NE, WA, IN, NY, SD and VA,
Code Information
Lot 413849