Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI. The device intended use is a clinical chemistry reagent for the in vitro, quantitative determination of direct bilirubin in serum on Hitachi analyzers.
This recall has been terminated (originally issued April 17, 2009).
- Company
- Pointe Scientific, Inc.
- Recall Initiated
- February 2, 2009
- Posted
- April 17, 2009
- Terminated
- October 13, 2010
- Recall Number
- Z-1202-2009
- Quantity
- 24 kits
- Firm Location
- Canton, MI
- Official Source
- View on FDA website ↗
Reason for Recall
The product performance fails due to precipitation of the R2 component.
Distribution
Worldwide Distribution -- USA, Chile and Mexico.
Lot / Code Info
HB936-120, Lot Number: 731801, exp. 11/2011 and HB936-294, Lot Number: 817103, exp. 5/2012.
Root Cause
Process control
Action Taken
Consignees were notified by "Urgent: Medical Device Recall" letter dated February 2, 2009 and mailed on February 6, 2009, and instructed to conduct the recall to the retail level if they had further distributed the product, to destroy any stocks on hand, and to complete and return the "Recall Return Response Form" via mail, e-mail, or fax (734-483-1592) to Point Scientific, Inc. Direct questions to the firm's Technical Support Department at 1-800-757-5313 or 1-734-487-8300.