Home › DRG International Inc › Progesterone, 17 a-Hydroxy- (Neonate) (MW) ELISA
Progesterone, 17 a-Hydroxy- (Neonate) (MW) ELISA
DRG International Inc · Model EIA-1429 · UDI-DI 00840239014290
JLX
Prescription
10
510(k) clearances
7
Adverse events
3
Recalls
22
Facilities
Description
The quantitative determination of 17-hydroxyprogesterone concentration in human whole blood by a microplate enzyme immunoassay, colorimetric.
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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