FDA Medical Device Recalls (openFDA)
DRG International, Inc.: 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 number
- Z-0258-2025
- 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
- Status
- Open, Classified
- Initiated
- 2024-09-13
- Posted
- 2024-10-29
- Terminated
- not on file
- 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.
- Root cause
- Process change control
- Action
- DRG issued Urgent Field Safety Notification on 9/17/24 via email. Letter states reason for recall, health risk and action to take: Please check your inventory for the respective lot and ensure that the proper acceptance ranges provided below are used to validate the assay. Immediately reply to email: qa@drg-international.com to confirm this notice and your compliance.
- Quantity
- 504 units
- Distribution
- AZ, CA, NH Foreign: Austria Belgium Georgia Germany Greece India Irak Italy Netherlands Poland Romania Russia Singapore Spain Tunesia Vietnam
- Lot, serial or model codes
- Lot Code: 04048474012927 (DRG Instruments GmbH) lots: 22K024 and 22K034
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JLX
- Firm FEI
- 2245285
- Firm city
- Springfield
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28