Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 625 ml, Catalog no. A7526-625, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188

FDA Recall Z-1112-2008 · Posted 2008-05-22

Recalling FirmPointe Scientific, Inc.
Recall StatusTerminated
Product CodeCKA
Date Initiated2007-12-14
Date Terminated2008-09-15
Product Quantity955 for all products.

Reason for Recall

Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.

Firm Action

Pointe Scientific notified consignees via Urgent Medical Device Recall letters dated 12/14/07, instructed to dispose of the product and to send back a reply form to request replacement product.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution - USA, Bolivia, Canada, Chile, China, Cyprus, Greece, Indonesia, Israel, Korea, Mexico, Pakistan, Panama, Peru, Philippines, Republic of Yemen, Russia, South Africa, Trinidad, Ukraine and West Indies.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K941287LIQUID ALT(SGPT) REAGENT SETPointe Scientific, Inc., · 1994-05-03

Official Source

View FDA Recall →

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

↑