FDAFDA · Food and drugs·Recall number Z-1358-2019
ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.
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 8K25-04; Lot 01018H000
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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