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LH-Serum ELISA
DRG Instruments Gesellschaft mit beschränkter Haftung · Model EIA-1289 · UDI-DI 04048474012897
CEP
Prescription
10
510(k) clearances
74
Adverse events
6
Recalls
78
Facilities
Description
The DRG LH ELISA Kit is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of the Luteinizing Hormone (LH) in serum.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-03-25 | Ortho-Clinical Diagnostics, Inc | Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quali |
| 2021-09-22 | bioMerieux, Inc. | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed result |
| 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. |
| 2012-11-05 | Beckman Coulter Inc. | Beckman Coulter Inc. (BEC) has demonstrated that real time stability testing of hLH Calibrator of certain lots have failed the 13-month and 14-month time points. Per BEC's real ti |
| 2006-11-22 | Abbott Laboratories MPG | The lots of ARCHITECT LH Reagent List 6C25-22, have the potential to generate patient specimen results that are elevated. Correlation studies have demonstrated an upward shift in |
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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.