Home › DRG International Inc › Salivary Progesterone HS ELISA
Salivary Progesterone HS ELISA
DRG International Inc · Model SLV-5911 · UDI-DI 00840239059116
JLS
Prescription
10
510(k) clearances
152
Adverse events
21
Recalls
47
Facilities
Description
Enzyme immunoassay for the in vitro diagnostic quantitative measurement of active free progesterone (a female hormone) in saliva.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 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 |
| 2019-07-10 | Siemens Healthcare Diagnostics, Inc. | There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration for additional progest |
| 2019-07-10 | Siemens Healthcare Diagnostics, Inc. | There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration for additional progest |
| 2019-06-06 | DRG Instruments GmbH | Salivary Progesterone assay may observe a higher percentage of samples with low results. Saliva samples in the low measuring range of the kit {< 20 pg/ml) were assayed and producin |
| 2018-11-21 | Abbott Ireland Diagnostics Division | Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle n |
| 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. |
| 2018-02-13 | Tosoh Bioscience Inc | Falsely elevated progesterone assay values will occur when using certain progesterone assay part numbers due to cross reactivity of DHEA-S, a metabolite of the DHEA (dehydroepiandr |
| 2018-02-13 | Tosoh Bioscience Inc | Falsely elevated progesterone assay values will occur when using certain progesterone assay part numbers due to cross reactivity of DHEA-S, a metabolite of the DHEA (dehydroepiandr |
| 2017-12-22 | Arrow International Inc | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. |
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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.