Abbott recalls ARCHITECT C Peptide Calibrators due to Mexico license renewal documentation error. All units until new license is obtained are affected. No immediate action needed.
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.
Abbott is recalling ARCHITECT C Peptide Calibrators because of a Mexico license renewal documentation error. This affects all units until a new license is obtained, but no action is required at this time.
The recall is due to an error in the Mexico license renewal documentation process. This means the product may not be legally authorized for use in Mexico until a new license is obtained. The hazard is a regulatory compliance issue, not a direct safety risk.
Healthcare providers using ARCHITECT C Peptide Calibrators for diabetes testing in Mexico are affected. Patients using these calibrators for abnormal insulin secretion diagnosis may be at risk if the license issue continues.
Check for lot number 03619E000 with expiration date 08APR2020 on the ARCHITECT C Peptide Calibrator. The product is used for diabetes testing in patients with abnormal insulin secretion.
Verify the lot number and expiration date on the calibrator to confirm if it's affected.
Abbott recalls ARCHITECT C Peptide Calibrators due to an error in the Mexico license renewal documentation process.
The recall is a regulatory compliance issue, not a direct safety risk. No injuries are reported.
No action is required at this time. The product remains safe for use until a new license is obtained.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1894-2020 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1894-2020 from Abbott. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
