Lower riskMedical device recall · FDA · Published December 21, 2021
DRG C-Peptide ELISA Test Kits: Low Standard ODs May Cause Invalid Results
DRG International recalls C-Peptide ELISA test kits where low standard optical density may cause invalid runs and delayed patient results. Affected kits have specific catalog numbers and expiration dates.
DRG International recalls certain C-Peptide ELISA test kits that may produce invalid results if the standard optical density is too low. This could delay patient results and requires immediate attention from healthcare providers using these kits. Read more at govinfonow.com/recall/61414-drg-c-peptide-elisa-test-kits-low-standard-ods-may.
“DRG C-Peptide ELISA Test Kits: Low Standard ODs May Cause Invalid Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61414-drg-c-peptide-elisa-test-kits-low-standard-ods-may. Based on FDA recall #Z-0896-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0896-2022%22&limit=1).
The FDA announced on 2021-12-21 that DRG International, Inc. voluntarily recalled its C-Peptide ELISA IVD measurement kits due to potential invalid test runs. The hazard involves standards with optical densities too low, which may cause delayed patient results.
How to tell if you have it
Brand: DRG International
Product: C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine
Catalog #: EIA-1293
Lot # 20K061 / Expiration date 2022-06-30
Lot # 20K071 / Expiration date 2022-07-31
Lot # 20K081 / Expiration date 2022-08-31
Quantity: 3 Kits
Distribution: NY
The hazard
According to the FDA, optical densities (ODs) of the standards that are too low (less than 0.6 ODmax) may cause invalid runs. This defect can lead to delayed patient results.
Context
GovInfoNow's records show DRG International, Inc. has had 6 other recalls on record since 2021-10-18. Other recent recalls of similar products include Sperm Ab ELISA Test Kit Recall (2026-07-02), T4 Total ELISA Kit recall (2025-06-04), and DRG Hybrid-XL Insulin Recall (2024-10-07). Other recent recalls of similar products include Siemens Atellica CH A1c_E Hemoglobin Test (2026-02-23), Stago STA Liatest D-Di (2026-02-05), and Meridian Bioscience Revogene C. difficile Test Recall (2025-12-05).
How to tell if you have this one
Check for catalog number EIA-1293 with lot numbers 20K061 (expires June 30, 2022), 20K071 (expires July 31, 2022), or 20K081 (expires August 31, 2022).
Brand
DRG International
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Expiration
Verify the expiration date on the kit label matches the dates listed: June 30, 2022 for lot 20K061; July 31, 2022 for lot 20K071; August 31, 2022 for lot 20K081.
Where it went and when
Where it was distributed
Distributed in New York.
Listed by the agency
Not listed
FDA distribution: “NY” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New York.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0896-2022 (December 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0896-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.