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IMMAGE
Beckman Coulter, Inc. · Model 446470 · UDI-DI 15099590230463
DEH
Prescription
10
510(k) clearances
82
Adverse events
4
Recalls
18
Facilities
Description
IMMAGE Immunochemistry Systems LAM Lambda Light Chain Reagent
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 calibrator point 6, whic |
| 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 users moving to thi |
| 2012-11-28 | The Binding Site Group, Ltd. | Calibration curve activity has increased over time in the kit lots listed. |
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