FDA recall record · openFDA

DRG International, Inc.

4 FDA recalls on record (2024–2025) — 4 device. 4 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in repeating th 1

The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range info 1

The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument using the re-c 1

An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded 1

Recalls

DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361 Class II 2024-10-07 Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total Class III 2025-06-04 Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay fo Class III 2024-07-05 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-O Class III 2024-09-13

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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