FDA Enforcement
Class III
Ongoing
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
Recall: Z-0258-2025
·
Reported November 6, 2024
Enforcement
- Recall Number
- Z-0258-2025
- Event ID
- 95429
- Classification
- Class III
- Status
- Ongoing
- Product Type
- Devices
- Firm
- DRG International, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- November 6, 2024
- Initiation Date
- September 13, 2024
- Classification Date
- October 29, 2024
- Address
- 841 Mountain Ave, N/A, Springfield, NJ, 07081-3437, United States
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
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.
Code Info
Lot Code: 04048474012927 (DRG Instruments GmbH) lots: 22K024 and 22K034
Distribution
AZ, CA, NH Foreign: Austria Belgium Georgia Germany Greece India Irak Italy Netherlands Poland Romania Russia Singapore Spain Tunesia Vietnam
Quantity
504 units