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Terminated

Alkaline Phosphatase Buffer Mfg. for Alfa Wassermann Diagnostic Technologies LLC, Caldwell, N.J. in 8.4 mL and 30 mL containers. In vitro diagnostic.

FDA Recall Z-1391-06 · Posted 2006-08-10

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.

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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