ABX Diagnostics Inc Pentra 80 and Pentra 80XL Hematology Analyzers Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pentra 80 and Pentra 80XL Hematology Analyzers
Brand
ABX Diagnostics Inc
Lot Codes / Batch Numbers
All Serial numbers.
Products Sold
All Serial numbers.
ABX Diagnostics Inc is recalling Pentra 80 and Pentra 80XL Hematology Analyzers due to Software defect, instrument may erroneously give a result of '0' or '---'.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software defect, instrument may erroneously give a result of '0' or '---'.
Recommended Action
Per FDA guidance
Firm sent a notification/recall letter on April 8, 2004. They plan to modify the software in August 2004.
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