The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0716-2013·Announced 2013-01-30

Abbott i-Stat cTnI Cartridges Recalled for Incorrect Barcode

Abbott Point of Care Canada Limited is recalling 10 boxes of i-Stat cTnI cartridges from lot P12179 due to incorrect barcodes on the cartridge portion pack.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling/packaging error (incorrect barcode) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Abbott Point of Care Canada Limited is recalling 10 boxes of i-Stat cTnI cartridges from lot P12179. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test used for the quantitative measurement of cardiac troponin I in whole blood or plasma, which aids in the diagnosis and treatment of myocardial infarction and risk stratification of patients with acute coronary syndromes.

The recall was initiated because the company determined that the 10 affected boxes have an incorrect barcode applied to the cartridge portion pack. The affected product is identified by lot number P12179 and list numbers 06F15-03, O6F15-04, 03P90-25, and 600-9009-25. The total quantity involved is 560 boxes, with 25 cartridges in each box, and the product was distributed worldwide.

Healthcare facilities and users should check their inventory for i-Stat cTnI cartridges with lot number P12179. If the product is found, it should be removed from use and returned to the distributor or the manufacturer as directed. This recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and…
Manufacturer
Abbott Point of Care Canada Limited
Category
Medical Device — In Vitro Diagnostics
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)

  • List number 06F15-03
  • O6F15-04
  • 03P90-25
  • 600-9009-25 Lot number P12179

Distribution

Distribution scope not specified by the agency.

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