Radiometer America Inc D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers.
Brand
Radiometer America Inc
Lot Codes / Batch Numbers
Lot Code: R0308, Expiration Date: 4/07, Lot Code: R0309, Expiration Date: 5/07, and Lot Code: R0310, Expiration Date: 5/07.
Products Sold
Lot Code: R0308, Expiration Date: 4/07; Lot Code: R0309, Expiration Date: 5/07; and Lot Code: R0310, Expiration Date: 5/07.
Radiometer America Inc is recalling D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers. due to The recalled membranes cause the status value of the pH and electrolyte electrodes to be offset causing readings outside of the acceptable range.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The recalled membranes cause the status value of the pH and electrolyte electrodes to be offset causing readings outside of the acceptable range.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026