Liquid Alkaline Phosphatase Reagent Set for the quantitative determination of alkaline phosphatase in serum, Manufactured by Pointe Scientific, Inc.; Catalog nos. A7516-150, A7516-450, A7516-625, HA716-246, HA716-2400, HA916-302 and HA916-492. In vitro diagnostic.
FDA Recall Z-1388-06 · Posted 2006-08-10
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Recalling FirmPointe Scientific, Inc.
Recall StatusTerminated
Product CodeCJE
Date Initiated2006-06-09
Date Terminated2007-11-19
Product Quantity890 L total, all products
Reason for Recall
The reagent may be contaminated with microorganisms.
Firm Action
Consignees were notified via recall letter dated 6/9/06 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, including USA, Bolivia, Cameroon, China, Cyprus, Egypt, Greece, India, Israel, Kenya, Korea, Lebanon, Malaysia, Mexico, Nepal, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Russia, Singapore, Thailand, Trinidad, Turkey, Ukraine United Arab Emirates and Venezuela.
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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