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Insulin ELISA
DRG Instruments Gesellschaft mit beschränkter Haftung · Model EIA-2935 · UDI-DI 04048474029352
CFP
Prescription
10
510(k) clearances
102
Adverse events
8
Recalls
37
Facilities
Description
The DRG Insulin ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Insulin in serum and plasma (lithium heparin or EDTA plasma).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-07 | DRG International, Inc. | The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument using the re-calibration R1 and R2 of the device or find controls out of s |
| 2023-11-21 | Beckman Coulter, Inc. | There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with the DxI 9000 Access Immunoassay Analyzer (APF 182 test definition version 6.7 and be |
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. |
| 2017-04-05 | Siemens Healthcare Diagnostics, Inc | Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304 standardization based on slope |
| 2012-04-30 | Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics has observed a negative bias in the Immulite Insulin assay. |
| 2012-04-30 | Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics has observed a negative bias in the Immulite Insulin assay. |
| 2007-09-19 | Beckman Coulter Inc | False negative results when used to test serum samples (as compared to plasma samples). |
| 2004-11-19 | Diagnostic Products Corp | Low bias of 10 to 40% at different levels of insulin in samples. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.