Abbott Troponin-I Controls Recalled for Missing Dry Ice
Abbott Laboratories is recalling ARCHITECT STAT High Sensitive Troponin-I Controls delivered without required dry ice 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 two units of ARCHITECT STAT High Sensitive Troponin-I Controls. These products are used to estimate test precision and detect systematic analytical deviations in the ARCHITECT i System when used for quantitative determination of cardiac troponin I in human serum and plasma.
The recall was initiated because the devices were delivered without the required dry ice. The affected lot is identified as 94347UIOO with code LN 3P25-11.
The distribution was limited to Latvia. Users should stop using the affected controls and contact Abbott Laboratories for further instructions.
The recalled product
- Product
- ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability when…
- 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 3P25-11
- Lot 94347UIOO
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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