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Atellica IM PRGE
Siemens Healthcare Diagnostics Inc. · Model 10995660 · UDI-DI 00630414599786
1
510(k) clearances
152
Adverse events
21
Recalls
47
Facilities
Description
Progesterone (PRGE) Atellica IM - RGT 90T
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.