FDAClass IIJanuary 30, 2013

Abbott Point of Care i-Stat cTnI cartridge. The i-Stat recall

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…

Why was Abbott Point of Care i-Stat cTnI cartridge. The i-Stat recalled?

APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Abbott Point of Care Canada Limited
Quantity
560 boxes (25 cartridges in each box)
Distribution
Worldwide Distribution.
Recall date
January 30, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls