Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzers, ABL-800 series, manufactured from 8/2004 through 9/2005.
This recall has been terminated (originally issued August 10, 2006).
- Company
- Radiometer America Inc
- Recall Initiated
- September 29, 2005
- Posted
- August 10, 2006
- Terminated
- April 17, 2012
- Recall Number
- Z-1387-06
- Quantity
- 196 devices
- Firm Location
- Westlake, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Under certain circumstances, the ABL 700 &800 Series Blood Gas Analyzers may experience leakage current into the measuring system. Consequently, the analyzers intermittently provide incorrect (too low) result values for Calcium (Ca) and Sodium (Na).
Distribution
Nationwide.
Lot / Code Info
All analyzers manufactured from 8/2004-9/2005. The devices contain serial numbers 902-441RxxxNxxx. The Rxxx number denotes manufacturing run, and the Nxxx number denotes the individual instrument within the run.
Root Cause
Other
Action Taken
The consignees were notified of this recall by a letter, dated 9/29/2005. The letter informs the customers of this potential problem and the availability of new updated software which will correct the problem. The letter goes on to inform the customer that a Radiometer Service Engineer wil be contacting them shortly in order to arrange for a convenient time to install the software update. Along with the letter, the customer is provided a copy of an additional page and a CD concerning the function and operation of the new software, which is to be added to the customer''s Operator''s Manual.