—#47058

Product

BD Unopette -- System Tests (Erythrocyte Fragility Test Kit). Catalog # 365830, Exp Date 2006-06, Manufactured by BD in San Lorenzo, Puerto Rico.

FDA product code: GKE — Osmotic Fragility Testing
Device class: Class 1
Medical specialty: Hematology
Affected lot / code info: Catalog #365830 -- Lot numbers: 5014328 -- exp. June 2006; 5159075 -- exp. July 2006.

Why it was recalled

Formulation problems-lower pH of the solutions may increase Red Blood Cell hemolysis

Root cause (FDA determination)

Other

Action the firm took

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

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: World wide-USA, Canada, Europe, Asia Pacific.

Timeline

Recall initiated: 2005-06-01
Posted by FDA: 2006-08-26
Terminated: 2006-08-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #47058. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.