The Recall Desk
LowFDA (Devices)·Z-0192-2013·Announced 2012-11-14

Abbott Recalls Cliniqa Liquid QC Cardiac Marker Control for i-STAT

Abbott Point of Care is recalling specific lots of Cliniqa Liquid QC Cardiac Marker Control for i-STAT because results may be generated below the lower value assignment range.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The agency classification is Class III, which the rubric defines as unlikely to cause adverse health consequences, typically resulting in a score of 1 or 2.

Plain-English summary

Abbott Point of Care (APOC) is recalling Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1, Level 2, and Level 3. The affected products include List Numbers 06F12-09, 06F12-10, and 06F12-11, with Lot Numbers 071039, 081039, and 091039 respectively. The total quantity involved is 154 boxes, with each box containing six 3ml plastic bottles.

The recall was initiated because APOC determined that results may be generated below the lower value assignment range for some vials. These products are assayed human plasma used to verify the integrity of newly received i-STAT CK-MB cartridges.

The affected products were distributed worldwide, including nationwide in the United States and in Italy. Specific US states mentioned include AZ, GA, ID, IL, LA, MD, MO, MN, NC, NV, OK, PA, TN, TX, VA, and WI. Users should stop using the affected lots and contact Abbott Point of Care for further instructions.

The recalled product

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 (Lis
Manufacturer
Abbott Point Of Care Inc.
Category
Medical Device — Laboratory Control
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1 (List #06F12-09
  • Lot Number 091039)

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

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