FDA · Medical device recall

VITROS ECi Immunodiagnostic System… and 1 more product

Jan. 27, 2012

Date posted by the FDA: Jan. 27, 2012
Status: Terminated
Filed by: Ortho-Clinical Diagnostics
Distribution pattern: 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, Panama, Singapore, Spain, and Venezuela.

2 products in this recall

VITROS ECi Immunodiagnostic System…

Product: VITROS ECi Immunodiagnostic System, Catalog No. 8633893 --- COMMON/USUAL NAME: VITROS ECi System -- Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester, NY 14626 --- All systems that have Software Version 3.8 or below installed and on which the VITROS Total B-hCG II Reagent Pack (human chorionic gonadotropin) is processed. Product Usage: For in vitro diagnostic use only. To perform random access, batch and STAT immunodiagnostic assays on human fluid specimens
Reason: 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.
Quantity: Domestic: 808; Foreign: 1113
Codes and lots: Serial Numbers between 30000127 and 30002743. All VITROS¿ ECi/ECiQ systems that have Software Version 3.8 or below installed and on which the VITROS¿ Total B-hCG II (human chorionic gonadotropin) Reagent Packs is processed are affected by this correction. --- Note: All systems that are installed worldwide have Software Version 3.8 or lower installed on them, but Total B-hCG is not processed on all systems worldwide.
Recall started: Aug. 24, 2011
Device type: Fluorometer, For Clinical Use
Root cause (FDA): Software design
What the company told customers: 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.
Recall number: Z-0923-2012

VITROS ECiQ Immunodiagnostic System…

Product: VITROS ECiQ Immunodiagnostic System, Catalog No. 1922814 --- COMMON/USUAL NAME: VITROS ECiQ System --- Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester, NY 14626 --- All systems that have Software Version 3.8 or below installed and on which the VITROS Total B-hCG II Reagent Pack (human chorionic gonadotropin) is processed. Product Usage: For in vitro diagnostic use only. To perform random access, batch and STAT immunodiagnostic assays on human fluid specimens
Reason: 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 B-hCG II Reagent Packs, Lots 0484 and above.
Quantity: Domestic: 906, Foreign: 1294
Codes and lots: Serial Numbers between 30003000 and 30005177; All VITROS¿ ECi/ECiQ systems that have Software Version 3.8 or below installed and on which the VITROS¿ B-hCG II (human chorionic gonadotropin) Reagent Packs is processed are affected by this correction. --- Note: All systems that are installed worldwide have Software Version 3.8 or lower installed on them, but B-hCG is not processed on all systems worldwide.
Recall started: Aug. 24, 2011
Device type: Fluorometer, For Clinical Use
Root cause (FDA): Software design
What the company told customers: 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.
Recall number: Z-0924-2012

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0923-2012, Z-0924-2012. The agency record governs; check it and the company before acting.

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