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

IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074.

FDA Recall Z-0884-05 · Posted 2005-06-11

Recalling FirmInternational Remote Imaging Systems Inc
Recall StatusTerminated
Product CodeJJW
Date Initiated2005-04-29
Date Terminated2012-05-07
Product Quantity107

Reason for Recall

Nonconformance to performance specifications.

Firm Action

Firm telephoned customers April 29, 2005 requesting return of product. All customers were contacted as of May 4, 2005.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K945913IRISPEC URINE CHEMISTRY CONTROL PART A AND BInternational Remote Imaging Systems · 1995-04-05

Official Source

View FDA Recall →

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

↑