Reported May 22, 2019 · Terminated
ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the…
Abbott Laboratories
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Laboratories · 100 Abbott Park Rd Bldg Ap8b · Abbott Park, IL · 60064-3502
Is this the product you have?
- ARCHITECT
- Intact PTH Controls - Product UsageThe 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
- Lot codes and dates
LN 8K25-12Lot 01018I000
- Amount recalled
- 1 unit
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Why it was recalled
Devices were delivered without the required dry ice.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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