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

Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System, Catalog number AS4010B

FDA Recall Z-1471-2008 · Posted 2008-08-22

Recalling FirmBiogenex Laboratories
Recall StatusTerminated
Product CodeKEY
Date Initiated2008-01-24
Date Terminated2011-01-08
Product Quantity10 units distributed.

Reason for Recall

Bulk reagent dispensing mechanism may break resulting in reagent spill and possible exposure to chemicals.

Firm Action

The firm initiated written notification on 01/24/2008. The firm has asked its consignee to inform its consignees of the recall.

Root Cause

Component design/selection

Distribution Pattern

Product was distributed to a single distributor, which further distributed the product.

Official Source

View FDA Recall →

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

↑