CLASS II Device recall · Reported 15 Aug 2012 · FDA Enforcement Report
I-stat PT/INR cartridge Abbott Point of Care Inc. Abbott recalled
Abbott Point Of Care is recalling I-stat PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This, distributed nationwide in the US. The recall was initiated on 1 Mar 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2157-2012
- FDA event ID
- 62536
- Recalling firm
- Abbott Point Of Care, Princeton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Mar 2012
- FDA classified
- 8 Aug 2012
- Reported
- 15 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Patient Monitors
Timeline
| 1 Mar 2012 | Recall initiated by company | |
| 8 Aug 2012 | Classified by FDA | +160 days |
| 15 Aug 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.
Product as listed by the FDA
I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.
Where it was distributed
Worldwide Distribution -- (USA) nationwide
Questions about this recall
Why was it recalled?
The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.
Which lots are affected?
List number 04J50-01 04J5O-02 03P89-24 Lots begininng with R11 or R12
Where was it sold?
Worldwide Distribution -- (USA) nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Abbott Point Of Care
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | i-STAT EG6+ cartridge recalled by Abbott Point Of Care | Abbott Point Of Care | Other | Nationwide |
| Device | CLASS II | i-STAT EG7+ cartridge recalled by Abbott Point Of Care | Abbott Point Of Care | Other | Nationwide |
| Device | CLASS II | i-STAT G3+ cartridge recalled by Abbott Point Of Care | Abbott Point Of Care | Other | Nationwide |
| Device | CLASS II | i-STAT EG7+ cartridge recalled by Abbott Point Of Care | Abbott Point Of Care | Other | Nationwide |
| Device | CLASS II | i-STAT CG8+ cartridge recalled by Abbott Point Of Care | Abbott Point Of Care | Other | Nationwide |
Other Patient Monitors recalls
All 1,022| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Passport Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | T1 Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | cPM Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | BeneVision Series Telemetry Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | Panorama and Telemetry Monitoring System recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |