Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product Code: NK001.T This kit is intended
FDA device recall Z-1072-2017 · posted 2017-01-23 · Terminated
Recall details
- Recalling firm
- The Binding Site Group, Ltd.
- Reason for recall
- Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
- Action taken
- Binding Site sent an Important Information letter dated September 30, 2014, Customers were instructed to retain the notification for records and additional instructions with the firm stating they were updating the instructions for use. Customers with questions were advised to contact their Binding Site representative or technical.service@bindingsite.co.uk.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CFN
- Distribution
- Worldwide Distribution - US including n FL, OH, TN, MN, NW, MI, CA. and Internationally to Canada, France, UK, Spain, Germany, Czech Republic, Belgium, Italy, Australia, Brazil, Chile, China, Costa Ri
- Date initiated
- 2014-09-11
- Date posted
- 2017-01-23
- Date terminated
- 2017-05-03
- Location
- Birmingham, United Kingdom
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T (K012295) | The Binding Site, Ltd. | 2001-08-20 |