DRG International, Inc. recalls Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-456…
Reason for recall
An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the kit by 2 months (i.e., 2026-03-31 instead of 2026-01-31). The expiration dates on the bottle labels were correct (i.e., 2026-01-31).
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
Lot / code information
- Catalog #
- EIA-4568
- UDI
- 04048474045680
- Lot #
- 304K034
What the firm is doing
On June 4, 2025 FIELD SAFETY NOTICE letters were sent to customers. Action to be taken by distributors and end-users: Please check your inventory for the respective lot. Please use the CoA provided with this FSN. If you require corrected outer kit box label for your documentation, please contact DRG. If you have transferred any of the affected products to another laboratory, please provide them with a copy of this letter. If you have any questions concerning this issue, please do not hesitate to contact us.
DistributionShow detailsHide
Worldwide - US Nationwide distribution in the states of CA, MA, PA and the countries of Germany, Hong Kong, Moldova.
Use of the product is not likely to cause adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2265-2025
- FDA device classification · CDXOfficial FDA classification for this device type
- CFR regulation · 21 CFR 862.1700The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find DRG International, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class III recalls
Heraeus Medical GmbH (Dental Division) recalls Heraeus
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process.…
- For Clinical Use Cement Mixer
- Under Investigation by firm
Heraeus Medical GmbH (Dental Division) recalls Heraeus
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process.…
- For Clinical Use Cement Mixer
- Under Investigation by firm
Philips Ultrasound, Inc recalls Philips X7-2 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Diagnostic Ultrasonic Transducer
- Device Design