Abbott Laboratories CELL-DYN 3200 Diluent/Sheath Reagent, List Number 03H79-01,Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CELL-DYN 3200 Diluent/Sheath Reagent, List Number 03H79-01,Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
Brand
Abbott Laboratories
Lot Codes / Batch Numbers
Lot Numbers: 14465I2, 15597I2, 15598I2, 16752I2, 16753I2, 16754I2, 17943I2, 17946I2, 17947I2, 17949I2, 17950I2, 17952I2, 17953I2, 17954I2, 18107I2, 18108I2, 18109I2, 18110I2
Products Sold
Lot Numbers: 14465I2, 15597I2, 15598I2, 16752I2, 16753I2, 16754I2, 17943I2, 17946I2, 17947I2, 17949I2, 17950I2, 17952I2, 17953I2, 17954I2, 18107I2, 18108I2, 18109I2, 18110I2
Abbott Laboratories is recalling CELL-DYN 3200 Diluent/Sheath Reagent, List Number 03H79-01,Distributed and Manufactured by: Abbott D due to Elevated platelet background count results-some products may show a higher than expected platelet background count when used on the CELL-DYN 3200 Syst. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Elevated platelet background count results-some products may show a higher than expected platelet background count when used on the CELL-DYN 3200 System and report patient results that are unacceptable-out-of-range
Recommended Action
Per FDA guidance
On September 29, 2004, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be disposed.
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 noticeDistribution
As reported by FDA
GA, IL, PA, TX, PR
Page updated: Jan 10, 2026