Z-0192-2013Class III

Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039)...

Name: Z-0192-2013 Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039)...
Creator: Abbott Point Of Care Inc.
Published: 2012-07-19
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-07-19 / Terminated / root cause: manufacturing process

FDA source

Abbott Point Of Care Inc. began a recall of 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... on 2012-07-19. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0192-2013
Classification: Class III
Status: Terminated
Initiated: 2012-07-19
Posted: 2012-11-02
Terminated: 2013-06-20
Recalling firm: Abbott Medical
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.
Product code: JJT Enzyme Controls (Assayed And Unassayed)
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0192-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0192-2013	Class III	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-02

Product code JJT

K030768Class ICliniqa Liquid Qc Cardiac Marker Control Levels 1, 2 & 3, Tri-LevelCliniqa Corporation / cleared 2003-03-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)