FDAFDA · Food and drugs·Recall number Z-1360-2019
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.
Published May 22, 2019 · Recall initiated: April 9, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Devices were delivered without the required dry ice.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Abbott Laboratories
- Distributor
- Distribution to Latvia.
- Lot
- LN 3P25-02; Lot 93284UIOO
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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