Dade Behring Inc. Rte 896, Glasgow Business Community Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13.
Brand
Dade Behring Inc. Rte 896, Glasgow Business Community
Lot Codes / Batch Numbers
Lot numbers 544531 to 544548 and 544502 to 544504.
Products Sold
Lot numbers 544531 to 544548 and 544502 to 544504.
Dade Behring Inc. Rte 896, Glasgow Business Community is recalling Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13. due to decrease in product stability after reconstitution and reduced stability on board certain instrument systems. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
decrease in product stability after reconstitution and reduced stability on board certain instrument systems
Recommended Action
Per FDA guidance
The recalling firm issued a recall letter to their customers informing them of the problem and the need to use internal quality controls with the analyzers. The letter instructed customer to discard lot # 544545 and reduce the stability for the other lot numbers involved.
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