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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm March 16, 2005
Date Posted June 21, 2005
Recall Status1 Terminated 3 on June 30, 2006
Recall Number Z-0912-05
Recall Event ID 31502
510(K)Number K992571  
Product Classification Activated Whole Blood Clotting Time - Product Code JBP
Product i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test.
Code Information i-STAT Catalog Number -- 420300; Abbott Catalog Number -- 07G01-01 (USA and Canada); Abbott Catalog Number -- 07G10-02 (Rest of world).  Lot Numbers: R04174B; R04175; R04175A; R04183; R04183A; R04183B; R04183C; R04190A; R04190B; R04205; R04205A; R04212A; R04212B; R04233; R04239; R04245; R04245A; R04245B; R04253; R04261; R04261A; R04262; R04274; R04274A; R04275; R04293; R04293A; R04294; R04294A; R04305; R04305A; R04305B; R04306; R04309; R04309A; R04315; R04315A; R04315B; R04322; R04323; R04323A; R04329; R04337; R04337A; R04342; R04343; R04350; R04350A; R04350B; R05006; R05014; R05014A; R05032B; R05032C; R05043; R05043A; R05044; R05048B; R05048C.
Recalling Firm/
Manufacturer		 Abbott Laboratories
104 Windsor Center Dr
East Windsor NJ 08520-1407
For Additional Information Contact Paul VanDerWerf
609-469-0242
Manufacturer Reason
for Recall		 Misidentification of Celite ACT cartridge as kaolin ACT Cartridge in the analyzer.
FDA Determined
Cause 2		 Other
Action The firm provided an 'Urgent Letter', acknowledgement form, floppy disks, and labels to all customers who received the celite ACT cartridge.
Quantity in Commerce 298006 cartridges
Distribution The cartridges have been distributed to hospitals and clinics nationwide. The cartridges have been distributed to Austria, Australia, Canada, Switzerland, China, Colombia, Germany, France, Greece, Hong Kong, India, New Zealand, and Singapore. There are 15 VA hospitals identified. There are 3 government and military accounts.
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 = JBP and Original Applicant = I-STAT CORP.
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