Abbott Recalls ARCHITECT HbA1C Calibrators Shipped Without Dry Ice
Abbott Laboratories is recalling ARCHITECT HbA1C Calibrators in Latvia because they were delivered without the required dry ice.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classifies this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The issue is a packaging/shipping defect (missing dry ice) rather than a direct product hazard.
Plain-English summary
Abbott Laboratories is recalling ARCHITECT HbA1C Calibrators, which are used for the calibration of the ARCHITECT i System for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood. The recall involves 1 unit with Lot 902920500 and code LN 4P72-01.
The recall was initiated because the devices were delivered without the required dry ice. This product was distributed to Latvia.
The U.S. Food and Drug Administration classifies this recall as Class III. Users should contact Abbott Laboratories for further instructions regarding the affected units.
The recalled product
- Product
- ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood.
- Manufacturer
- Abbott Laboratories
- Hazard
- Affected units
- 1
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)
- LN 4P72-01
- Lot 902920500
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 9 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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