FDA Device recall Z-0192-2013
Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09
- FDA Device
- Class III
- terminated
- Published 2012-11-14
On 2012-11-14 the FDA classified a Class III recall of Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09 by Abbott Point, citing 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 #06F1….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0192-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-07-19 |
| Published | 2012-11-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Abbott Point |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1 (List #06F12-09; Lot Number 071039) Cliniqa Liquid QC Ca…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) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0192-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.