Recall Z-0258-2025— DRG International, Inc.
Class III · Ongoing
Class III FDA medical device recall by DRG International, Inc., initiated 2024-09-13. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- DRG International, Inc.
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2024-09-13
- Firm location
- Springfield, NJ, United States
Product 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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.