Abbott Laboratories White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell lysing reagent, List Number 01H77-01, Supplied in 3.8L bottles, Abbott Laboratories, Abbott Park, IL 60064 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell lysing reagent, List Number 01H77-01, Supplied in 3.8L bottles, Abbott Laboratories, Abbott Park, IL 60064
Brand
Abbott Laboratories
Lot Codes / Batch Numbers
Lot Numbers: 51749i2, 51754i2 and 56675i2.
Products Sold
Lot Numbers: 51749i2, 51754i2 and 56675i2.
Abbott Laboratories is recalling White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red due to Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.
Recommended Action
Per FDA guidance
Consignees were notified by a Product Recall letter sent 12/19/07. The letter instructs users to discontinue use of affected product and destroy any remaining inventory. Users were requested to return a customer reply form. For additional information, contact 1-877-4ABBOTT.
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, AK, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WV, WI
Page updated: Jan 10, 2026