Recall Z-0180-2012
Abbott Point Of Care Inc. · initiated September 29, 2011
Product
i-Stat cTnI cartridges Is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples.
Codes / lots: List Number 03P90-25; 06F15-03; 06F15-04; 600-9009-25 All lots beginning with letter T. Various lots. LOT List Number EXP. DATE T11059 03P90-25 28-Sep-11 T11059A 03P90-25 28-Sep-11 T11059B 03P90-25 28-Sep-11 T11060 03P90-25 28-Sep-11 T11060A 03P90-25 28-Sep-11 T11060B 03P90-25 28-Sep-11 T11061 03P90-25 28-Sep-11 T11061A 03P90-25 28-Sep-11 T11061C 03P90-25 28-Sep-11 T11062A 03P90-25 28-Sep-11 T11062B 03P90-25 28-Sep-11 T11063 03P90-25 28-Sep-11 T11063A 03P90-25 28-Sep-11 T11064 03P90-25 28-Sep-11 T11065 03P90-25 28-Sep-11 T11066 03P90-25 28-Sep-11 T11067 03P90-25 28-Sep-11 T11068 06F15-03 28-Sep-11 T11068A 03P90-25 28-Sep-11 T11068B 03P90-25 28-Sep-11 T11069 06F15-03 28-Sep-11 T11069A 03P90-25 28-Sep-11 T11069B 03P90-25 28-Sep-11 T11070 03P90-25 28-Sep-11 T11070A 03P90-25 28-Sep-11 T11070B 03P90-25 28-Sep-11 T11070C 03P90-25 28-Sep-11 T11070D 03P90-25 28-Sep-11 T11072 03P90-25 28-Sep-11 T11072A 03P90-25 28-Sep-11 T11073 06F15-03 28-Sep-11 T11073A 03P90-25 28-Sep-11 T11073B 03P90-25 28-Sep-11 T11074 03P90-25 14-Oct-11 T11074A 03P90-25 14-Oct-11 T11075 03P90-25 14-Oct-11 T11075A 03P90-25 14-Oct-11 T11075B 03P90-25 14-Oct-11 T11076 06F15-03 14-Oct-11 T11076A 03P90-25 14-Oct-11…
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.
FDA-determined cause: Material/Component Contamination
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.
Details
- Recall number
- Z-0180-2012
- Initiated
- September 29, 2011
- Posted by FDA
- November 10, 2011
- Terminated
- March 11, 2013
- Product code
- MMI – Immunoassay Method, Troponin Subunit
- Quantity
- 1,688,755 cartridges
- Distribution
- Worldwide Distribution
- Recalling firm
- Abbott Point Of Care Inc., Princeton, NJ