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Terminated

Liquid Alkaline Phosphatase Reagent Set; Catalog No. A7516-150-SAM, In vitro diagnostic; for the quantitative determination of alkaline phosphatase in serum, Sold by Pointe Scientific, Inc

FDA Recall Z-1360-2008 · Posted 2008-03-27

Recalling FirmPointe Scientific, Inc.
Recall StatusTerminated
Product CodeCJE
Date Initiated2008-02-07
Date Terminated2009-06-12
Product Quantity6

Reason for Recall

May be contaminated with microorganisms.

Firm Action

Consignees were notified via recall letter, Urgent Medical Device, dated 2/7/08, to cease using the product, conduct a recall to the user level, destroy product on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. International consignees were notified via email.

Root Cause

Other

Distribution Pattern

Worldwide-USA, Canada, Chile, Cyprus, Ecuador, Greece, India, Italy, Jamaica, Korea, Nigeria, Pakistan, Philippines, Poland, Turkey and The West Indies.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K973588LIQUID ALKALINE PHOSHATASE REAGENT SETPointe Scientific, Inc., · 1997-10-22

Official Source

View FDA Recall →

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

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