DRG International, Inc. Recall 95429
Description: 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292
DRG International, Inc. Recall 95429 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0258-2025 |
| Event ID | 95429 |
| Event Description | 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292 |
| Product Type | Devices |
| Distribution | AZ, CA, NH Foreign: Austria Belgium Georgia Germany Greece India Irak Italy Netherlands Poland Romania Russia Singapore Spain Tunesia Vietnam |
| Quantity | 504 units |
| Recall Reason | 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 the defect, the device failed to provide results, which may result in a delay in obtaining test results and a remote chance of an adverse health risk. |
| Device Classification | 20241106 |
| Device Code Info | Lot Code: 04048474012927 (DRG Instruments GmbH) lots: 22K024 and 22K034 |
| Center Classification Date | 20241029 |
| Recall Initiation Date | 20240913 |
| Recalling Firm | DRG International, Inc. |
| Initial Notification | |
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