Abbott Recalls ARCHITECT Sirolimus Calibrators Shipped Without Dry Ice
Abbott Laboratories is recalling ARCHITECT Sirolimus 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 classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Abbott Laboratories is recalling one unit of ARCHITECT Sirolimus Calibrators (Lot 46K15718, LN 1L76-01) distributed to Latvia. The recall was initiated because the devices were delivered without the required dry ice.
These calibrators are used for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human whole blood. The missing dry ice may affect the integrity of the product, though the source text does not specify the resulting impact on test accuracy or patient safety.
The FDA has classified this recall as Class III, which indicates that use of, or exposure to, the violative product is not likely to cause adverse health consequences. Users should contact Abbott Laboratories for further instructions regarding the affected units.
The recalled product
- Product
- ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus 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 1L76-01
- Lot 46K15718
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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