Home › Diagnostic Automation, Inc. › AccuDiag™ 17-alpha-OH Progesterone ELISA
AccuDiag™ 17-alpha-OH Progesterone ELISA
Diagnostic Automation, Inc. · Model DACD1292-15 · UDI-DI 00894175000770
10
510(k) clearances
7
Adverse events
3
Recalls
22
Facilities
Description
AccuDiag™ 17-alpha-OH Progesterone ELISA A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of 17-hydroxyprogesterone in a clinical specimen, using an enzyme immunoassay (EIA) method
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-13 | DRG International, Inc. | The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range information on the High and Low Control Component labels. Due to |
| 2023-04-05 | Siemens Healthcare Diagnostics, Inc. | Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias |
| 2023-04-05 | Siemens Healthcare Diagnostics, Inc. | Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias |
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