Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 Recalled by Abbott Point Of Care Inc. Due to Abbott Point of Care (APOC) has determined that...

Date: July 19, 2012
Company: Abbott Point Of Care Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Point Of Care Inc. directly.

Affected Products

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.

Quantity: 154 (06F12-09 (74) boxes; 06F12-10 (35) boxes and 06F12-11 (45) boxes.) 1 box contains six, 3ml plastic bottles.

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Abbott Point Of Care Inc.

Abbott Point Of Care Inc. has 28 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report