Becton Dickinson & Company BD Unopette -- System Tests (Erythrocyte Fragility Test Kit). Catalog # 365830, Exp Date 2006-06, Manufactured by BD in San Lorenzo, Puerto Rico. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BD Unopette -- System Tests (Erythrocyte Fragility Test Kit). Catalog # 365830, Exp Date 2006-06, Manufactured by BD in San Lorenzo, Puerto Rico.
Brand
Becton Dickinson & Company
Lot Codes / Batch Numbers
Catalog #365830 -- Lot numbers: 5014328 -- exp. June 2006, 5159075 -- exp. July 2006.
Products Sold
Catalog #365830 -- Lot numbers: 5014328 -- exp. June 2006; 5159075 -- exp. July 2006.
Becton Dickinson & Company is recalling BD Unopette -- System Tests (Erythrocyte Fragility Test Kit). Catalog # 365830, Exp Date 2006-06, M due to Formulation problems-lower pH of the solutions may increase Red Blood Cell hemolysis. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Formulation problems-lower pH of the solutions may increase Red Blood Cell hemolysis
Recommended Action
Per FDA guidance
Recall letters were sent via first class mail on 7/11/2005 by US mail, return receipt requested. A second notification was sent 8/4/2005
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