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Terminated

Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI., Catalog # HB936-1250.

FDA Recall Z-1014-2010 · Posted 2010-03-05

Recalling FirmPointe Scientific, Inc.
Recall StatusTerminated
Product CodeCIG
Date Initiated2009-07-29
Date Terminated2010-12-06
Product Quantity2

Reason for Recall

R2 reagent component may fail because it may contain R1 reagent. The reagent was rendered inoperative and would not pass the required quality control (calibration and quality control testing) before beginning running the bilirubin assay.

Firm Action

Consignee was notified by letter dated 7/29/2009 and instructed to identify and notify them at once of this product recall. Product is to be returned or destroyed. Customers with questions should contact the firm directly.

Root Cause

Error in labeling

Distribution Pattern

California.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040391TOTAL BILIRUBIN REAGENT SETPointe Scientific, Inc., · 2004-06-02

Official Source

View FDA Recall →

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

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