Roche Diagnostics Corp. Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400 plus, 700 and 800 analyzers, as well as, Cobas c 501 analyzer; Catalog Number 20737836322. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400 plus, 700 and 800 analyzers, as well as, Cobas c 501 analyzer; Catalog Number 20737836322.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
All Reagent Lots (including Lots 67941901, exp. 4/30/07, 68139201, exp. 6/30/07 and 68156201, exp. 8/31/07)
Products Sold
All Reagent Lots (including Lots 67941901, exp. 4/30/07; 68139201, exp. 6/30/07 and 68156201, exp. 8/31/07)
Roche Diagnostics Corp. is recalling Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400 plus, 700 and due to The lower detection limit (LDL) may be a higher value than stated in the labeling. Note: To resolve this issue, the Digoxin LDL claim has been revise. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The lower detection limit (LDL) may be a higher value than stated in the labeling. Note: To resolve this issue, the Digoxin LDL claim has been revised to 0.3 ng/mL for all reagent lots.
Recommended Action
Per FDA guidance
A recall letter dated 3/16/07 was sent to each consignee advising them that the LDL claim in the label has been revised to 0.3 ng/ml for all reagent lots.
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