Abbott Recalls Architect C Peptide Reagents Due to Licensing Error
Abbott Laboratories is recalling 65 kits of ARCHITECT C Peptide Reagents 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 error (license renewal) rather than a product defect or safety hazard, fitting the 'Low' severity criteria for documentation issues.
Plain-English summary
Abbott Laboratories is recalling 65 kits of ARCHITECT C Peptide Reagents, Calibrators, and Controls. The product is used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion, including diabetes mellitus. The recall affects specific lots: 01719F000 (Exp Date 14MAY2020) and 02519E000 (Exp Date 09APR2020).
The recall was initiated due to an error in the renewal documentation process for the license in Mexico. All in-date products are being recalled until a new license is obtained. The source text states that the product was distributed internationally only in Mexico, with no US distribution.
There are no reports of illness or injury associated with this recall. Consumers and healthcare providers in Mexico should stop using the affected lots and contact Abbott Laboratories for further instructions.
The recalled product
- Product
- ARCHITECT C Peptide Reagent - 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 01719F000 (Exp Date 14MAY2020)
- 02519E000 (Exp Date 09APR2020)
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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