Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera — Class II medical device recall Z-1070-2017
Terminated recall by The Binding Site Group, Ltd., reported 2017-02-01, distributed in CA, FL, MI, MN, OH, TN. Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and w
| Recall number | Z-1070-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Binding Site Group, Ltd., Birmingham, N/A, United Kingdom |
| Recall initiated | 2014-09-11 |
| Classified | 2017-01-23 |
| Reported by FDA | 2017-02-01 |
| Terminated | 2017-05-03 |
| Distributed | CA, FL, MI, MN, OH, TN |
| Countries outside the US | AU, BE, BR, CA, CL, CN, CR, CZ, DE, ES, FR, GB, IT, KW, NZ, OM, PK, PT, TR, TW |
Product
Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent and lgG Antisera for use on Hitachi 911/912/917 and Hitachi Modular P Product Code LK009.H/LK001.H This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents
Reason for recall
Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.