ARCHITECT C Peptide Calibrator — Class III medical device recall Z-1894-2020
Terminated recall by Abbott Laboratories, reported 2020-05-13. Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Ca
| Recall number | Z-1894-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Abbott Park, IL, United States |
| Recall initiated | 2020-04-01 |
| Classified | 2020-05-05 |
| Reported by FDA | 2020-05-13 |
| Terminated | 2020-09-01 |
| Countries outside the US | MX |
| Quantity | 65 kits |
| Lot numbers | 03619E000 |
| Expiration dates | 2020-04-08 |
Product
ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
Reason for recall
Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a new license is obtained.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1894-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.