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Anti-Insulin ELISA
DRG Instruments Gesellschaft mit beschränkter Haftung · Model EIA-3608 · UDI-DI 04048474036084
CFP
Prescription
10
510(k) clearances
102
Adverse events
8
Recalls
37
Facilities
Description
Anti-Insulin ELISA is a test system for the quantitative measurement of IgG class autoantibodies against insulin in human serum or 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.