Food, drugs, devices › DRG International, Inc.
Device recall: C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog #
DRG International, Inc. (Springfield, NJ) initiated this device recall on 21 Dec 2021; FDA lists 1 product record under event 89680, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 12 Feb 2024. Initiation: voluntary: firm initiated. DRG International, Inc. has 6 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
DRG International, Inc., Springfield, NJ.
Reason for recall
"ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible"
Distribution
"NY"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0896-2022 | C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293 | 3 Kits | Class II | Terminated | 13 Apr 2022 |
Context
Other enforcement events for DRG International, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 4 Jun 2025 | Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELI | Device | Class III | 1 |
| 7 Oct 2024 | DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361 | Device | Class II | 1 |
| 13 Sep 2024 | 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-O | Device | Class III | 1 |
| 5 Jul 2024 | Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for | Device | Class III | 1 |
| 18 Oct 2021 | Total Thyroxine (T4) ELISA; REF EIA-1781 | Device | Class II | 1 |
All 6 events for DRG International, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "NY"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 12 Feb 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.