17-OH Progesterone ELISA Kit Recalled for Labeling Discrepancy
DRG International is recalling 504 units of its 17-OH Progesterone ELISA kit (Model EIA-1292) due to mismatched control acceptance ranges between the Certificate of Analysis and component labels, causing test failure.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with a labeling discrepancy causing device failure. No illnesses or injuries reported; source explicitly states only a remote chance of adverse health risk, making this a minor labeling error with functional consequence rather than a reported-harm scenario.
Plain-English summary
DRG International, Inc. is recalling 504 units of its 17-OH Progesterone ELISA 96 well kit (Model EIA-1292), an enzyme immunoassay used for quantitative measurement of 17-OH Progesterone in serum or plasma. The affected units are distributed in Arizona, California, and New Hampshire, as well as Austria, Belgium, Georgia, Germany, Greece, India, Iraq, Italy, Netherlands, Poland, Romania, Russia, Singapore, Spain, Tunisia, and Vietnam.
The High and Low Control acceptance ranges shown in the Certificate of Analysis did not match the acceptance range information printed on the High and Low Control Component labels. This discrepancy caused the devices to fail in providing test results, which may delay diagnosis and carries a remote chance of adverse health risk.
The specific affected lots are 22K024 and 22K034 (Lot Code 04048474012927 from DRG Instruments GmbH). Healthcare providers and laboratory professionals should discontinue use of affected units and contact the manufacturer for instructions on replacement or remediation.
The recalled product
- 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
- Manufacturer
- DRG International, Inc.
- Hazard
- mis-labeling
- device-failure
- delayed-diagnosis
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: 04048474012927 (DRG Instruments GmbH) lots: 22K024 and 22K034
Distribution
Distributed in 3 states:
- AZ
- CA
- NH
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