Abbott Laboratories CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer
Brand
Abbott Laboratories
Lot Codes / Batch Numbers
List Number: 07H22-01, lot numbers: 16328 and 29401
Products Sold
List Number: 07H22-01, lot numbers: 16328 and 29401
Abbott Laboratories is recalling CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer due to T-Cell test results and the respective absolute counts for the CELL-DYN Sapphire instrument using CD3/4/8 reagents can be overestimated by as much as . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
T-Cell test results and the respective absolute counts for the CELL-DYN Sapphire instrument using CD3/4/8 reagents can be overestimated by as much as 13%.
Recommended Action
Per FDA guidance
The firm has sent notification letters dated Dec. 16, 2005 to all consignees requesting discontinuing of use, destruction of CD3/4/8 reagent if the lab does not plan to run on a CELL-DYN 4000 system.
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