Binding Site Human IgM Kit recall
Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two…
Why was Binding Site Human IgM Kit recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 413849
- 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…
- Recalling firm
- The Binding Site Group, Ltd.
- Quantity
- 60
- Distribution
- U.S Distribution to states of: CA, IL, PA, FL, NE, WA, IN, NY, SD and VA,
- Recall date
- December 19, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)