Abbott Recalls ARCHITECT Intact PTH Calibrators Due to Missing Dry Ice
Abbott Laboratories is recalling two units of ARCHITECT Intact PTH Calibrators because they were delivered without the required dry ice.
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, 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 two units of ARCHITECT Intact PTH Calibrators. These products are used for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.
The recall was initiated because the devices were delivered without the required dry ice. The affected units are identified by Lot 01018H000 and code LN 8K25-04.
The products were distributed to Latvia. Consumers and healthcare facilities should stop using the affected units and contact Abbott Laboratories for further instructions.
The recalled product
- Product
- ARCHITECT Intact PTH Calibrators - 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
- 2
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 8K25-04
- Lot 01018H000
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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