CLASS II Device recall · Reported 18 Jul 2012 · FDA Enforcement Report
Fuso Analyzer 300F recalled by Abbott Point Of Care
Abbott Point Of Care is recalling Fuso Analyzer 300F, distributed nationwide in the US. The recall was initiated on 8 Sep 2011 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-1975-2012
- FDA event ID
- 62319
- Recalling firm
- Abbott Point Of Care, Princeton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Sep 2011
- FDA classified
- 9 Jul 2012
- Reported
- 18 Jul 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 8 Sep 2011 | Recall initiated by company | |
| 9 Jul 2012 | Classified by FDA | +305 days |
| 18 Jul 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387
Where it was distributed
Worldwide Distribution - USA (nationwide)
Questions about this recall
Is Fuso Analyzer 300F recalled?
Yes. Abbott Point Of Care recalled Fuso Analyzer 300F on 8 Sep 2011. The recall is Class II and its status is Terminated. Recall number Z-1975-2012.
Why was it recalled?
Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Which lots are affected?
FUSO Analyzer 300F 310003 All lots
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 21 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
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|---|---|---|---|---|---|
| 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 |
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Other Insulin Pumps & Glucose Monitors recalls
All 459| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Lead & Heavy Metals | Nationwide |