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Prolactin ELISA
DRG International Inc · Model EIA-1786 · UDI-DI 00840239017864
CFT
Prescription
10
510(k) clearances
247
Adverse events
6
Recalls
53
Facilities
Description
The Prolactin ELISA is intended for the quantitative determination of prolactin in human serum. The assay is useful in the diagnosis and treatment of disorders of the anterior pituitary and hypothalamus.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 2018-07-12 | Ortho Clinical Diagnostics Inc | The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated |
| 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. |
| 2017-03-21 | Siemens Healthcare Diagnostics, Inc. | The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension |
| 2012-08-07 | Siemens Healthcare Diagnostics, Inc | ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40 |
| 2009-08-03 | Beckman Coulter Inc. | The recall was initiated because Beckman Coulter has confirmed that the Active Prolactin ElLISA kit, lot number 890291 over estimates the expected dose values for patient serum sam |
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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.