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

Oral-Eze (R) Oral Fluid Collection System, manufactured by Capitol Vial, Inc., Auburn, AL 36832 Product Usage: IVD for drugs of abuse

FDA Recall Z-1101-2012 · Posted 2012-02-24

Recalling FirmCapitol Vial Inc
Recall StatusTerminated
Product CodeJKA
Date Initiated2011-10-07
Date Terminated2012-08-24
Product Quantity135,000 units

Reason for Recall

Low buffer fill volumes on Oral-Eze, an oral fluid collection system.

Firm Action

Thermo-Fisher Scientific/Capital Vial sent a Recall Notification letter dated October 7, 2011 to the sole consignee. The letter identified the affected product, problem, result impact and necessary actions to be taken. The consignee was instructed to discontinue use of the affected product and follow the necessary actions provided. If you have any questions regarding this information, call Michael Hect, Manufacturing Manager through Customer Service at (800) 772-8871.

Root Cause

Device Design

Distribution Pattern

(USA) Nationwide Distribution - in the state of KS

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K984361ORAL-EZE ORAL FLUID COLLECTION SYSTEMOsborn Laboratories, Inc. · 1999-01-13

Official Source

View FDA Recall →

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

↑