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 8K25-12
    • Lot 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 20, 2019 · Data as of Sep 19, 6:18 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.