17 OH-Progesterone ELISA EIA-1292Recalls & reported problems

DRG Instruments Gesellschaft mit beschränkter Haftung · The DRG 17-OH Progesterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-α-OH Progesterone (17-α-OHP) in serum or plasma (K2-EDTA, K3- EDTA, lithium heparin or citrate plasma 3.2 %). · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

Sep 13, 2024Class IIIOpen, Classified
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.
Z-0258-2025 · Root cause: Process change control · Recall details · FDA record ↗

Device details

UDI-DI	`04048474012927`
Brand	17 OH-Progesterone ELISA
Model	EIA-1292
Company	DRG Instruments Gesellschaft mit beschränkter Haftung
Product code	JLX · Radioimmunoassay, 17-Hydroxyprogesterone
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Nov 26, 2024

Device type (GMDN): 17-Hydroxyprogesterone IVD, kit, chemiluminescent immunoassay

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of 17-hydroxyprogesterone in a clinical specimen, using a chemiluminescent immunoassay method.

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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