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.
FDA Recall Z-1202-2009 · Posted 2009-04-17
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Recalling FirmPointe Scientific, Inc.
Recall StatusTerminated
Product CodeCIG
Date Initiated2009-02-02
Date Terminated2010-10-13
Product Quantity24 kits
Reason for Recall
The product performance fails due to precipitation of the R2 component.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution -- USA, Chile and Mexico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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