Abbott Laboratories CELL-DYNE 1700CS (Closed Sampler), list numbers 03H57-01, 03H57-03, manufactured by Abbott Hematology, Santa Clara, CA Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CELL-DYNE 1700CS (Closed Sampler), list numbers 03H57-01, 03H57-03, manufactured by Abbott Hematology, Santa Clara, CA
Brand
Abbott Laboratories
Lot Codes / Batch Numbers
Control Number 42285V 42283V 42261V 42262V 42279V 42184V96 40655V96 42268V 42284V 42267V 40437V96
Products Sold
Control Number 42285V 42283V 42261V 42262V 42279V 42184V96 40655V96 42268V 42284V 42267V 40437V96
Abbott Laboratories is recalling CELL-DYNE 1700CS (Closed Sampler), list numbers 03H57-01, 03H57-03, manufactured by Abbott Hematolog due to Use of Syringe LN 04H36-01 with the Die-cast syringe drive may result in leakage, leading to delay in reporting patient results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Use of Syringe LN 04H36-01 with the Die-cast syringe drive may result in leakage, leading to delay in reporting patient results.
Recommended Action
Per FDA guidance
A Product Correction Letter and Customer Rely Form were sent to all currently active Cell -Dyn Sapphire customer. New customers are being notified with a Product Information Letter. For questions regarding this information, U,S, customers should call Customer Support at 1-877-4ABBOTT. Customers outside the U.S., please contact your local hematology customer support representative.
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