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Terminated

AST R1 Reagent, 120 ml., Pointe Scientific, Inc., Canton, MI; Catalog no. 8-A7561-R1-120. For the quantitative determination of aspartate amoinotransferase in human serum

FDA Recall Z-0172-2009 · Posted 2008-10-22

Recalling FirmPointe Scientific, Inc.
Recall StatusTerminated
Product CodeCIT
Date Initiated2008-08-25
Date Terminated2009-11-27
Product Quantity25 vials

Reason for Recall

The R1 component may be contaminated with Serratia liquefaciens, resulting decreased absorbances and failure of the reagent to produce test results.

Firm Action

Consignees were notified via recall letter dated 8/22/08 and mailed 8/25/08 to examine their inventory, dispose of any recalled product found, and to notify the firm for replacements. Contact Pointe Scientific Inc., at 1-800-757-5313 for assistance.

Root Cause

Material/Component Contamination

Distribution Pattern

Nationwide, Bolivia, Ecuador, Greece, Indonesia, Mexico, Nepal, Philippines, Romania and Serbia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K941132LIQUID AST (SGOT)REAGENT SETPointe Scientific, Inc., · 1994-05-02

Official Source

View FDA Recall →

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

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