Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent; Catalog Nos. 7-A7516-R2-125, 7-A7516-R2-90 and 8-A7516-R2-30, In vitro diagnostic, 30 mL, 90 mL , 125 mL, and 400 mL containers, Sold by Pointe Scientific.
FDA Recall Z-1359-2008 · Posted 2008-03-27
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Recalling FirmPointe Scientific, Inc.
Recall StatusTerminated
Product CodeCJE
Date Initiated2008-02-07
Date Terminated2009-06-12
Product Quantity47
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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