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 used for the quantitative determination of cardiac troponin I (cTnI) in human serum and plasma with the ARCHITECT STAT High Sensitive Troponin-I reagent kit.
Reported: May 22, 2019 Initiated: April 9, 2019 #Z-1359-2019
Product Description
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 used for the quantitative determination of cardiac troponin I (cTnI) in human serum and plasma with the ARCHITECT STAT High Sensitive Troponin-I reagent kit.
Reason for Recall
Devices were delivered without the required dry ice.
Details
- Recalling Firm
- Abbott Laboratories
- Units Affected
- 2 units
- Distribution
- Distribution to Latvia.
- Location
- Abbott Park, IL
Frequently Asked Questions
What product was recalled? ▼
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 used for the quantitative determination of cardiac troponin I (cTnI) in human serum and plasma with the ARCHITECT STAT High Sensitive Troponin-I reagent kit.. Recalled by Abbott Laboratories. Units affected: 2 units.
Why was this product recalled? ▼
Devices were delivered without the required dry ice.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 22, 2019. Severity: Low. Recall number: Z-1359-2019.
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