Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall iStat cTnI cartridges

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall iStat cTnI cartridges see related information
Date Initiated by Firm September 29, 2011
Date Posted November 10, 2011
Recall Status1 Terminated 3 on March 11, 2013
Recall Number Z-0180-2012
Recall Event ID 60048
510(K)Number K031739  
Product Classification Immunoassay method, troponin subunit - Product Code MMI
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.
Code Information 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 T11076B 03P90-25 14-Oct-11 T11077 03P90-25 14-Oct-11 T11077A 03P90-25 14-Oct-11 T11078 03P90-25 14-Oct-11 T11079 03P90-25 14-Oct-11 T11079A 03P90-25 14-Oct-11 T11080 06F15-03 14-Oct-11 T11081 03P90-25 14-Oct-11 T11081A 03P90-25 14-Oct-11 T11081B 06F15-03 14-Oct-11 T11082 03P90-25 14-Oct-11 T11083 03P90-25 14-Oct-11 T11083A 03P90-25 14-Oct-11 T11083B 03P90-25 14-Oct-11 T11084 03P90-25 14-Oct-11 T11084A 03P90-25 14-Oct-11 T11087 03P90-25 14-Oct-11 T11088 03P90-25 28-Oct-11 T11088A 03P90-25 28-Oct-11 T11089A 03P90-25 28-Oct-11 T11089B 03P90-25 28-Oct-11 T11090 03P90-25 28-Oct-11 T11091 03P90-25 28-Oct-11 T11091A 03P90-25 28-Oct-11 T11091B 03P90-25 28-Oct-11 T11092 03P90-25 28-Oct-11 T11095 03P90-25 28-Oct-11 T11095A 03P90-25 28-Oct-11 T11096 03P90-25 28-Oct-11 T11096C 03P90-25 28-Oct-11 T11096D 03P90-25 28-Oct-11 T11097 03P90-25 28-Oct-11 T11097B 03P90-25 28-Oct-11 T11098 03P90-25 28-Oct-11 T11099 03P90-25 28-Oct-11 T11099A 03P90-25 28-Oct-11 T11100 03P90-25 28-Oct-11 T11101 03P90-25 28-Oct-11 T11101A 03P90-25 28-Oct-11 T11102 03P90-25 28-Oct-11 T11102A 03P90-25 28-Oct-11 T11102B 03P90-25 28-Oct-11 T11103 03P90-25 28-Oct-11 T11103A 03P90-25 28-Oct-11 T11104A 03P90-25 28-Oct-11 T11104B 06F15-03 28-Oct-11 T11105 06F15-03 14-Nov-11 T11105A 06F15-03 14-Nov-11 T11105B 06F15-03 14-Nov-11 T11107 03P90-25 14-Nov-11 T11107A 03P90-25 14-Nov-11 T11108 03P90-25 14-Nov-11 T11108A 03P90-25 14-Nov-11 T11108B 03P90-25 14-Nov-11 T11109 06F15-03 14-Nov-11 T11109B 06F15-03 14-Nov-11 T11110 03P90-25 14-Nov-11 T11110A 03P90-25 14-Nov-11 T11110B 03P90-25 14-Nov-11 T11110C 03P90-25 14-Nov-11 T11111 03P90-25 14-Nov-11 T11111A 03P90-25 14-Nov-11 T11112A 03p90-25 14-Nov-11 T11112B 03P90-25 14-Nov-11 T11113 03P90-25 14-Nov-11 T11113A 03P90-25 14-Nov-11 T11114 03P90-25 14-Nov-11 T11114A 03p90-25 14-Nov-11 T11115 03P90-25 14-Nov-11 T11115A 03P90-25 14-Nov-11 T11116 03P90-25 14-Nov-11 T11116A 06F15-03 14-Nov-11 T11117 03P90-25 14-Nov-11 T11118 03P90-25 14-Nov-11 T11118A 03P90-25 14-Nov-11 T11118B 03P90-25 14-Nov-11 T11118C 03P90-25 14-Nov-11 T11119 03P90-25 28-Nov-11 T11120 03P90-25 28-Nov-11 T11120A 03P90-25 28-Nov-11 T11121 03P90-25 28-Nov-11 T11121A 06F15-03 28-Nov-11 T11122 06f15-03 28-Nov-11 T11123 03P90-25 28-Nov-11 T11123B 03P90-25 28-Nov-11 T11123C 03P90-25 28-Nov-11 T11124 03P90-25 28-Nov-11 T11124A 03P90-25 28-Nov-11 T11124B 03P90-25 28-Nov-11 T11125 03P90-25 28-Nov-11 T11125A 03P90-25 28-Nov-11 T11125C 03P90-25 28-Nov-11 T11126 03P90-25 28-Nov-11 T11127 03P90-25 28-Nov-11 T11127A 03P90-25 28-Nov-11 T11128 03P90-25 28-Nov-11 T11128B 03P90-25 28-Nov-11 T11129A 03P90-25 28-Nov-11 T11129B 03P90-25 28-Nov-11 T11131A 03P90-25 28-Nov-11 T11132 03P90-25 28-Nov-11 T11132A 03P90-25 28-Nov-11 T11132B 03P90-25 28-Nov-11 T11133 03P90-25 28-Nov-11 T11136 03P90-25 14-Dec-11 T11136A 03P90-25 14-Dec-11 T11137 03P90-25 14-Dec-11 T11137A 03P90-25 14-Dec-11 T11137B 03P90-25 14-Dec-11 T11138 06F15-03 14-Dec-11 T11138A 06F15-03 14-Dec-11 T11138B 06F15-03 14-Dec-11 T11139 03P90-25 14-Dec-11 T11139A 03P90-25 14-Dec-11 T11139B 03P90-25 14-Dec-11 T11140 03P90-25 14-Dec-11 T11142 03P90-25 14-Dec-11 T11143 03P90-25 14-Dec-11 T11143A 03P90-25 14-Dec-11 T11144 03P90-25 14-Dec-11 T11144A 03P90-25 14-Dec-11 T11145A 03P90-25 14-Dec-11 T11147 03P90-25 14-Dec-11 T11147A 03P90-25 14-Dec-11 T11149 03P90-25 28-Dec-11 T11150 03P90-25 28-Dec-11 T11150A 03P90-25 28-Dec-11 T11151 03P90-25 28-Dec-11 T11151A 03P90-25 28-Dec-11 T11151B 03P90-25 28-Dec-11 T11153 03P90-25 28-Dec-11 T11153A 03P90-25 28-Dec-11 T11153B 03P90-25 28-Dec-11 T11154 06F15-03 28-Dec-11 T11156 06F15-03 28-Dec-11 T11156A 03P90-25 28-Dec-11 T11157 03P90-25 28-Dec-11 T11158 03P90-25 28-Dec-11 T11158B 03P90-25 28-Dec-11 T11159 03P90-25 28-Dec-11 T11160 03P90-25 28-Dec-11 T11163A 03P90-25 28-Dec-11 T11164 03P90-25 28-Dec-11 T11165C 03P90-25 28-Dec-11 T11166 03P90-25 14-Jan-11 T11167 06F15-03 14-Jan-11 T11172 03P90-25 14-Jan-11 T11172A 03P90-25 14-Jan-11 T11173 03P90-25 14-Jan-11 T11174 03P90-25 14-Jan-11 T11174B 03P90-25 14-Jan-11 T11175 06F15-03 14-Jan-11 T11177 03P90-25 14-Jan-11 T11186 03P90-25 28-Jan-11 T11202 06F15-03 28-Jan-11 
Recalling Firm/
Manufacturer		 Abbott Point Of Care Inc.
400 College Rd E
Princeton NJ 08540-6607
For Additional Information Contact Mr. Larry Krasley
609-454-9292
Manufacturer 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 2		 Material/Component Contamination
Action 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.
Quantity in Commerce 1,688,755 cartridges
Distribution Worldwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MMI and Original Applicant = I-STAT CORPORATION
-
-