Reported Nov 14, 2012 · Terminated
Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039) Cliniqa Liquid…
Abbott Point Of Care Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Point Of Care Inc. · 400 College Rd E · Princeton, NJ · 08540-6607
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | Lot Number 071039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 2 (List Number 06F12-10 |
| 2 | Lot Number 081039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 3 (List Number 06F12-11 |
| 3 | Lot Number 091039) Usage: Assayed human plasma which may be used to verify the integrity of newly received i-STAT CK-MB cartridges. |
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1 (List #06F12-09 2 Lot Number 071039) Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 2 (List #06F12-10 3 Lot Number 081039) Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 3 (List #06F12-11 4 Lot Number 091039) - Amount recalled
- 154 (06F12-09 (74) boxes; 06F12-10 (35) boxes and 06F12-11 (45) boxes.) 1 box contains six, 3ml plastic bottles.
Where it was sold
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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