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U.S. Department of Health and Human Services

Class 3 Device Recall Cliniqa Liquid QCTM Cardiac Marker Control

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 Class 3 Recall
Cliniqa Liquid QCTM Cardiac Marker Control
see related information
Date Posted November 02, 2012
Recall Status1 Terminated on June 20, 2013
Recall Number Z-0192-2013
Recall Event ID 63309
Premarket Notification
510(K) Number
K030768 
Product Classification Enzyme Controls (Assayed And Unassayed) - Product Code JJT
Product Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 2 (List Number 06F12-10; Lot Number 081039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 3 (List Number 06F12-11; Lot Number 091039) Usage: Assayed human plasma which may be used to verify the integrity of newly received i-STAT CK-MB cartridges.
Code Information Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1 (List #06F12-09; Lot Number 071039) Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 2 (List #06F12-10; Lot Number 081039) Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 3 (List #06F12-11; Lot Number 091039)
Recalling Firm/
Manufacturer
Abbott Point Of Care Inc.
400 College Rd E
Princeton, New Jersey 08540-6607
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Mr. Joseph Kiceina
609-454-9494
Manufacturer Reason
for Recall
Abbott Point of Care (APOC) has determined that for the Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1 (List #06F12-09; Lot Number 071039); i-STAT Level 2 (List #06F12-10; Lot Number 081039); and i-STAT Level 3 (List #06F12-11; Lot Number 091039) results may be generated below the lower value assignment range for some vials.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination
Action The firm, Abbott Point of Care, Inc. (APOC), sent an "URGENT RECALL NOTICE" dated July 2012 via FED-EX on July 19, 2012. The recall notice identified the product, problem and the action needed to be taken by the customer. The customers were instructed to discontinue use of the control lot numbers; return all unused controls on the enclosed Customer Reply Form; If another institution was provided the controls, provide a copy of this notice to them. Note: if any used vials gave acceptable product performance, a review of the cartridge performance and associated patient results is not necessary) Note: APOC is shipping replacement products to customers facilities to minimize any disruption this might cause. If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-366-8020, option 1 or your Abbott Point of Care representative.
Quantity in Commerce 154 (06F12-09 (74) boxes; 06F12-10 (35) boxes and 06F12-11 (45) boxes.) 1 box contains six, 3ml plastic bottles.
Distribution Worldwide distribution: USA (nationwide) including states of: AZ, GA, ID, IL, LA, MD, MO, MN, NC, NV, OK, PA, TN, TX, VA and WI; and country of: Italy.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJT and Original Applicant = CLINIQA CORPORATION
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