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U.S. Department of Health and Human Services

Class 2 Device Recall BD Unopette System Tests (Erythrocyte Fragility Test Kit).

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 Class 2 Device Recall BD Unopette System Tests (Erythrocyte Fragility Test Kit).see related information
Date Initiated by FirmJune 01, 2005
Date PostedAugust 26, 2006
Recall Status1 Terminated 3 on August 25, 2006
Recall NumberZ-1446-06
Recall Event ID 35864
Product Classification Erythrocyte Fragility Test Kit - Product Code GKE
ProductBD Unopette -- System Tests (Erythrocyte Fragility Test Kit). Catalog # 365830, Exp Date 2006-06, Manufactured by BD in San Lorenzo, Puerto Rico.
Code Information Catalog #365830 -- Lot numbers: 5014328 -- exp. June 2006; 5159075 -- exp. July 2006.
FEI Number 2243072
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information ContactKevin Nolan
201-847-5651
Manufacturer Reason
for Recall		Formulation problems-lower pH of the solutions may increase Red Blood Cell hemolysis
FDA Determined
Cause 2		Other
ActionRecall 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
Quantity in CommerceLot # 5014328 - 1,980 kits; Lot 5159075 - 4,360 kits
DistributionWorld wide-USA, Canada, Europe, Asia Pacific.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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