Abbott Recalls Alinity i Anti-TPO Calibrators Due to Missing Dry Ice
Abbott Laboratories is recalling Alinity i Anti-TPO Calibrators in Latvia because they were delivered without 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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a packaging/shipping defect (missing dry ice) rather than a direct product hazard.
Plain-English summary
Abbott Laboratories is recalling Alinity i Anti-TPO Calibrators, which are used to calibrate the Alinity i analyzer for quantitative determination of thyroid peroxidase autoantibodies in human serum and plasma. The recall was initiated because the devices were delivered without the required dry ice.
The affected product is identified by Lot 84347UN18 and Code LN 09P3501. The recall is limited to distribution in Latvia.
Consumers and healthcare facilities should stop using the affected calibrators and contact Abbott Laboratories for further instructions or a replacement.
The recalled product
- Product
- ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma.
- 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 09P3501
- Lot 84347UN18
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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