CLASS II Device recall · Reported 13 Apr 2022 · FDA Enforcement Report
C-Peptide Elisa : Ivd measurement of C-Peptide in serum recalled
DRG International is recalling C-Peptide Elisa : Ivd measurement of C-Peptide in serum, plasma (Edta-, heparin- or, distributed in New York. The recall was initiated on 21 Dec 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0896-2022
- FDA event ID
- 89680
- Recalling firm
- DRG International, Springfield, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Dec 2021
- FDA classified
- 7 Apr 2022
- Reported
- 13 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 21 Dec 2021 | Recall initiated by company | |
| 7 Apr 2022 | Classified by FDA | +107 days |
| 13 Apr 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible
Product as listed by the FDA
C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
Where it was distributed
NY
Questions about this recall
Why was it recalled?
ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible
Which lots are affected?
Lot# / Expiration dates: 20K061 / 2022-06-30 20K071 / 2022-07-31 20K081 / 2022-08-31
Where was it sold?
NY
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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