Home › Device types › DEH
Lambda, Antigen, Antiserum, Control
FDA product code DEH · Class 2 · Immunology
39
Registered devices
82
Adverse events
4
Recalls
53
510(k) clearances
Devices with this code
FLC Control Level 2 — SEBIADiazyme — DIAZYME LABORATORIES, INC.Lambda light chains — SENTINEL CH. SPAFreelite® Human Lambda Free Kit for use on the SPAPLUS – Bulk Kit — THE BINDING SITE GROUP LIMITEDN FLC CONTROL SL1 — Siemens Healthcare Diagnostics Products GmbHFreelite® Human Lambda Free Kit for use on the Siemens BN™II - Bulk Kit — THE BINDING SITE GROUP LIMITEDSPIFE IFE-9 Pentavalent Antisera Kit — HELENA LABORATORIES CORPORATIONFreelite® Human Lambda Free Kit for use on the Beckman Coulter IMMAGE®/IMMAGE®80 — THE BINDING SITE GROUP LIMITEDN LATEX FLC lambda — Siemens Healthcare Diagnostics Products GmbHFreelite® Human Lambda Free Kit for use on the Roche Cobas Integra® - Bulk kit — THE BINDING SITE GROUP LIMITEDFreelite® Human Lambda Free Kit for use on the Roche cobas® c systems — THE BINDING SITE GROUP LIMITEDCAPILLARYS IMMUNOTYPING — SEBIADiazyme — DIAZYME LABORATORIES, INC.Poly Rb A-Hu Lambda LC — AGILENT TECHNOLOGIES SINGAPORE PTE LTDN FLC STANDARD SL — Siemens Healthcare Diagnostics Products GmbHOptilite Freelite Lambda Kit — THE BINDING SITE GROUP LIMITEDFreelite® Human Lambda Free Kit for use on the ADVIA® — THE BINDING SITE GROUP LIMITEDFLC Control Level 1 — SEBIAFreelite® Human Lambda Free Kit for use on the Siemens BN™II — THE BINDING SITE GROUP LIMITEDFLC Lambda — SEBIAFreelite® Human Lambda Free Kit for use on the Beckman AU® series — THE BINDING SITE GROUP LIMITEDN FLC CONTROL SL2 — Siemens Healthcare Diagnostics Products GmbHOptilite Freelite Lambda Free Bulk Kit — THE BINDING SITE GROUP LIMITEDPoly Rb A-Hu Lambda Free LC — AGILENT TECHNOLOGIES SINGAPORE PTE LTD
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-10-15 | The Binding Site Group, Ltd. | Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and cali |
| 2016-10-28 | The Binding Site Group, Ltd. | A change in the calibration curve causing an increase in false prozone flags. |
| 2016-07-05 | The Binding Site Group, Ltd. | Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L that are on average 33% lower than other Optilite Lambda Freelite batches. Therefore |
| 2012-11-28 | The Binding Site Group, Ltd. | Calibration curve activity has increased over time in the kit lots listed. |
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