i-Stat cTnI cartridges Is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparini

FDA device recall Z-0180-2012 · posted 2011-11-10 · Terminated

Recall details

Recalling firm

Abbott Point Of Care Inc.

Reason for recall

i-Stat cTnI cartridges beginning with letter "T" may exhibit a higher than expected variability in reported results. This increased variability may result in falsely elevated or falsely depressed results.

Action taken

APOC issued Urgent Recall Notices/Business Reply Forms dated September 2011 to consignees. The letter identified the affected product and explained the background of the problem. Customers are to discontinue use of the cartridges from the lots identified. All unused product will be credited and should be returned as instructed on the attached Business Reply Card. If the affected product was further distributed, a copy of the Recall Notice should be provided to those customers as well. APOC shipped replacement product in order to minimize any disruption. If replacement product has not been received then customers should contact Customer Service at 1-800-366-8020, option 5. Questions regarding this information should be directed to Abbott Point of Care Technical Support at 800-366-8020, Option 1 or customers' local APOC representative.

Root cause

Material/Component Contamination

Status

Terminated

Product code

MMI

Quantity affected

1,688,755 cartridges

Distribution

Worldwide Distribution

Date initiated

2011-09-29

Date posted

2011-11-10

Date terminated

2013-03-11

Location

Princeton, NJ

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