Abbott Recalls ARCHITECT Intact PTH Controls Due to Missing Dry Ice
Abbott Laboratories is recalling ARCHITECT Intact PTH Controls because they were delivered without required dry ice. The recall affects units distributed to Latvia.
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. The issue is a packaging/shipping defect (missing dry ice) rather than a direct product hazard.
Plain-English summary
Abbott Laboratories is recalling specific units of ARCHITECT Intact PTH Controls. These products are used for the calibration of the ARCHITECT iSystem when performing quantitative determinations of Intact PTH 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 01018I000 and Code LN 8K25-12. The distribution pattern indicates that these units were delivered to Latvia.
Consumers and healthcare facilities should stop using the affected units and contact Abbott Laboratories for further instructions or a replacement.
The recalled product
- Product
- ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH 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 8K25-12
- Lot 01018I000
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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