VITROS ECi Immunodiagnostic System, Catalog No. 8633893 --- COMMON/USUAL NAME: VITROS ECi System -- Ortho-Clinical Diagn

FDA device recall Z-0923-2012 · posted 2012-01-27 · Terminated

Recall details

Recalling firm

Ortho-Clinical Diagnostics

Reason for recall

Software defect; Ortho Clinical Diagnostics received complaints of observed results from diluted samples that were reported as <2.39 mIU/mL (IU/L) instead of the correct No Result, which is accompanied by an Invalid Dilution (ID) code. The diluted results were inconsistent with results from the neat (undiluted) sample, which was within the measuring range of 2.39 - 15,000 mIU/mL. OCD's investigation determined it is possible to obtain negatively biased results if samples are diluted and tested on the VITROS ECi/ECiQ System using VITROS Total B-hCG II Reagent Packs, Lots 0484 and above.

Action taken

Ortho Clinical Diagnostics (OCD) sent an URGENT Product Correction Notification letter dated August 24, 2011 via FedEx overnight letter to all US consignees with VITROS ECi/ECiQ Systems. Foreign Affiliates were also notified of the problem on August 24, 2011. The letters provided information regarding the affected product, the problem, the actions to be followed prior to reporting results from their laboratory and a Question and Answer Section. Customers were instructed to 1) Post the enclosed Procedure for Reviewing VITROS Total B-hCG II Results near the VITROS ECi/ECiQ System to advise operators of this issue and assist them in reviewing results from diluted samples; 2) Users should consult with their Laboratory Medical Director and request a physician to resolve any concerns users may have regarding previously reported results from Lots 0484 and above of VITROS Total B-hCG II Reagent Packs; 3) Complete and return the attached Confirmation of Receipt form upon receipt of this notification; and 4) Forward the information in this notification if you have distributed this product outside of your facility. For additional questions contact OCD Customer Technical Services at 1-800-421-331.

Root cause

Software design

Status

Terminated

Product code

KHO

Quantity affected

Domestic: 808; Foreign: 1113

Distribution

Worldwide Distribution - USA (nationwide) and including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panam

Date initiated

2011-08-24

Date posted

2012-01-27

Date terminated

2017-05-09

Location

Rochester, NY

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