Recall Z-1360-2019— Abbott Laboratories
Class III · Terminated
Class III FDA medical device recall by Abbott Laboratories, initiated 2019-04-09, terminated 2019-12-20. FDA's recall record names no specific 510(k) clearance for this event. Product: ARCHITECT STAT High Sensitive Troponin-I Calibrators - 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: Devices were delivered without the required dry ice..
- Recalling firm
- Abbott Laboratories
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-04-09
- Terminated
- 2019-12-20
- Firm location
- Abbott Park, IL, United States
Product description
ARCHITECT STAT High Sensitive Troponin-I Calibrators - 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.