D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers.
This recall has been terminated (originally issued August 2, 2006).
- Company
- Radiometer America Inc
- Recall Initiated
- June 17, 2005
- Posted
- August 2, 2006
- Terminated
- September 14, 2011
- Recall Number
- Z-1319-06
- Quantity
- 13 boxes/4 membranes per box
- Firm Location
- Westlake, OH
- Official Source
- View on FDA website ↗
Reason for Recall
The recalled membranes cause the status value of the pH and electrolyte electrodes to be offset causing readings outside of the acceptable range.
Distribution
Nationwide, including TX, OK, MI, CO, NY, and Canada.
Lot / Code Info
Lot Code: R0308, Expiration Date: 4/07; Lot Code: R0309, Expiration Date: 5/07; and Lot Code: R0310, Expiration Date: 5/07.
Root Cause
Other
Action Taken
The recalling firm notified their distributor/customers of this recall, via telephone on 6/17/2005, at which time, the customers were asked to destroy any and all suspect reference membranes found on-site and at their subaccount customer locations.
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