DRG recalls 17-OH Progesterone ELISA kits with mismatched control ranges that could delay test results and pose a remote health risk. Affected kits have specific model and lot numbers.
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.
DRG recalls certain 17-OH Progesterone ELISA kits because their control ranges don't match the certificate, which might delay test results and carry a remote health risk.
The kit's control ranges in the certificate don't match the labels, causing the device to fail and potentially delay test results. There's a remote chance of an adverse health risk if tests are delayed.
Lab users who purchased the specific model (EIA-1292) with lot numbers 22K024 or 22K034 from DRG Instruments GmbH. Those using the kits for medical testing are most at risk.
Check for model EIA-1292 with lot numbers 22K024 or 2:2K034. The kits are sold by DRG Instruments GmbH for medical testing.
Verify the model number (EIA-1292) and lot number (22K024 or 22K034) on the kit packaging.
The model number is EIA-1292.
Lot numbers 22K024 and 22K034.
The control ranges in the certificate don't match the labels, causing the device to fail and potentially delaying test results.
We’ve drafted a message you can send DRG to request your refund or repair — edit it as you like.
Subject: Recall Z-0258-2025 — DRG DRG Hello, I own a DRG that is covered by recall Z-0258-2025 from DRG. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
