FDAFDA · Food and drugs·Recall number Z-0258-2025
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
Published November 6, 2024 · Recall initiated: September 13, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- DRG International, Inc.
- Distributor
- AZ, CA, NH Foreign: Austria Belgium Georgia Germany Greece India Irak Italy Netherlands Poland Romania Russia Singapore Spain Tunesia Vietnam
- Lot
- Lot Code: 04048474012927 (DRG Instruments GmbH) lots: 22K024 and 22K034
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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