DRG International, Inc. Recall: 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassa
DRG International, Inc. Recall: 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassa is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: DRG International, Inc.; Product: 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement
| Recalling firm | DRG International, Inc. |
|---|---|
| Product | 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 |
| Reason for recall | 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. |
| Classification | Class III (least serious — unlikely to cause adverse health consequences) |
| Status | Ongoing |
| Distribution | AZ, CA, NH Foreign: Austria Belgium Georgia Germany Greece India Irak Italy Netherlands Poland Romania Russia Singapore Spain Tunesia Vietnam |
| Recall initiated | 20240913 |
| Recall number | Z-0258-2025 |
| Category | device |
| State | NJ |
| Country | United States |
$29/mo
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