Reported Jan 8, 2020 · Terminated

i-STAT cTnI cartridge

Abbott Point Of Care Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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 Point Of Care Inc. · 400 College Rd E · Princeton, NJ · 08540-6607

Is this the product you have?

  • i-STAT cTnI cartridge
Lot codes and dates
  • List Number06P23-25
  • UDI(01)00054749001986
Amount recalled
3,465,875

Where it was sold

Why it was recalled

i-STAT¿ cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed rate of quality check codes could be in the 3 to 5% range.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated May 4, 2020 · Data as of Sep 19, 5:21 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.