Abbott Laboratories CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, 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 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
Brand
Abbott Laboratories
Lot Codes / Batch Numbers
Lot Numbers: 10916I2, 10917I2, 10918I2, 10919I2, 10920I2, 10921I2
Products Sold
Lot Numbers: 10916I2, 10917I2, 10918I2, 10919I2, 10920I2, 10921I2
Abbott Laboratories is recalling CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured by: Abbott due to Incorrect Test Results-product may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient resu. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect Test Results-product may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that are unacceptable (out-of-range).
Recommended Action
Per FDA guidance
Recall Letter-On 2/24/04, the firm initiated the recall and its notification explaining the reason for the recall and requesting the product be destroyed
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
AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MI, MN, MS, MO, NV, NJ, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, VA, WV, WI, DC
Page updated: Jan 10, 2026