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
This recall has been terminated (originally issued July 9, 2012).
- Company
- Abbott Point Of Care Inc.
- Recall Initiated
- September 8, 2011
- Posted
- July 9, 2012
- Terminated
- January 28, 2013
- Recall Number
- Z-1975-2012
- Quantity
- 310003 -2203 units
- Firm Location
- Princeton, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Distribution
Worldwide Distribution - USA (nationwide)
Lot / Code Info
FUSO Analyzer 300F 310003 All lots
Root Cause
Device Design
Action Taken
Abbott Point Care sent an Urgent Product Recall letter dated September 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to confirm the number of affected product at their facility that were using the Old Battery Carrier. Fill out the affected Buesiness Reply Card and submit their facility information as per the instructions on the card. Upon the receipt of the New Battery Carriers, replace the Old Battery Center with the New Battery Center. Customers were instructed to immediately dispose of all Old Battery Carriers per local regulations. If customers forward the affected product to another facility, they should provide a copy of the recall letter to them and advise them to replace the carriers if required. For any questions call 800-366-8020, Option 1 or your Abbott Point of Care representative. For questions regarding this recall call 609-454-9272.