Abbott Laboratories, Inc ARCHITECT c8000 System Software, Version 2.11, Product List/Model #5F48-12, distributed by Abbot Laboratories, Irving, TX. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ARCHITECT c8000 System Software, Version 2.11, Product List/Model #5F48-12, distributed by Abbot Laboratories, Irving, TX.
Brand
Abbott Laboratories, Inc
Lot Codes / Batch Numbers
All lots/serial numbers.
Products Sold
All lots/serial numbers.
Abbott Laboratories, Inc is recalling ARCHITECT c8000 System Software, Version 2.11, Product List/Model #5F48-12, distributed by Abbot Lab due to System software assigns a calibrator default volume of 2.0uL when field is left empty by operator at time assay parameters set. Patient results could. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
System software assigns a calibrator default volume of 2.0uL when field is left empty by operator at time assay parameters set. Patient results could be affected if the volume required is not 2.0 uL.
Recommended Action
Per FDA guidance
Firm initiated recall to all consignees via letter dated 12/08/05.
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