Abbott Recalls C Peptide Calibrator Due to Mexico License Documentation Error
Abbott Laboratories is recalling 65 kits of ARCHITECT C Peptide Calibrator in Mexico due to an error in the license renewal documentation process.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III and is due to a documentation issue regarding a license renewal, which fits the rubric criteria for Low severity involving documentation issues.
Plain-English summary
Abbott Laboratories is recalling 65 kits of the ARCHITECT C Peptide Calibrator. This product is used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion, including diabetes mellitus.
The recall was initiated due to an error in the renewal documentation process for the license in Mexico. All in-date ARCHITECT C Peptide Reagents, Calibrators, and Controls are being recalled until a new license is obtained.
The affected products are identified by Lot Numbers 01819G000 with an expiration date of 12JUN2020. The distribution was international, specifically in Mexico, with no US distribution. Consumers and healthcare providers in Mexico should stop using the affected products and contact Abbott Laboratories for further instructions.
The recalled product
- 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.
- Manufacturer
- Abbott Laboratories
- Hazard
- Affected units
- 65
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Numbers 01819G000
- Exp Date 12JUN2020
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Abbott Laboratories under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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