The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2237-2012·Announced 2012-08-29

Abbott i-STAT cTnI Cartridges Recalled for Incorrectly Elevated Troponin Results

Abbott Point of Care is recalling i-STAT cTnI cartridges because they may produce incorrectly elevated cardiac troponin I results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device that may produce incorrect diagnostic results for a serious condition (myocardial infarction), which fits the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Abbott Point of Care Inc. is recalling i-STAT cTnI cartridges. These are in vitro diagnostic test cartridges used to measure cardiac troponin I in heparinized whole blood or plasma samples. The test is used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes.

The recall was initiated because the cartridges have the potential to exhibit incorrectly elevated cardiac troponin I results. The recall was expanded on July 19, 2012, to include additional information regarding user documentation.

The recall affects 7,057,675 cartridges in the United States and 772,400 cartridges outside the United States. The distribution was worldwide, including US nationwide and international markets. All lots are affected, including those with List Numbers 06F15-03, 06F15-04, 03P90-25, and 600-9009-25, associated with 510(K)K031739.

The recalled product

Product
i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac I troponin measurement cane be used as an aid in the diagnosis and…
Manufacturer
Abbott Point Of Care Inc.
Category
Medical Device — In Vitro Diagnostic
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • 510(K)K031739 List Number 06F15-03
  • 06F15-04
  • 03P90-25
  • 600-9009-25 All lots

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Abbott Point Of Care Inc.

See all →

Same hazard · mis labeling

See all →

Similar recalls