D 744 Chloride membrane, CI, REF Model #942-061, accessory to the ABL700 blood analyzer.
This recall has been terminated (originally issued August 1, 2006).
- Company
- Radiometer America Inc
- Recall Initiated
- February 1, 2005
- Posted
- August 1, 2006
- Terminated
- November 18, 2011
- Recall Number
- Z-1314-06
- Quantity
- 85/4 unit boxes
- Firm Location
- Westlake, OH
- Official Source
- View on FDA website ↗
Reason for Recall
The CI membrane units generate too low values for status and sensitivity during calibration.
Distribution
Nationwide.
Lot / Code Info
Lot Code: R0053.
Root Cause
Other
Action Taken
The recalling firm sent a letter, dated 2/05, to all of their consignees.The letter instructed the customers to discontinue use of the product and discard any remaining stock which they had on hand. The letter was accompanied by replacement chloride membranes to replace the customer''s portion of the suspect lot.
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