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Terminated

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

FDA Recall Z-1446-06 · Posted 2006-08-26

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeGKE
Date Initiated2005-06-01
Date Terminated2006-08-25
Product QuantityLot # 5014328 - 1,980 kits; Lot 5159075 - 4,360 kits

Reason for Recall

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

Firm Action

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

Root Cause

Other

Distribution Pattern

World wide-USA, Canada, Europe, Asia Pacific.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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