Z-0629-2011

ARCHITECT iVancomycin Reagent; an in vitro chemiluminescent microparticle immunoassay (CMIA) for the...

Name: Z-0629-2011 ARCHITECT iVancomycin Reagent; an in vitro chemiluminescent microparticle immunoassay (CMIA) for the...
Creator: Abbott Laboratories
Published: 2010-09-13
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-09-13 / Terminated

FDA source

Abbott Laboratories began a recall of ARCHITECT iVancomycin Reagent; an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or... on 2010-09-13. The reason FDA records is "The assay may produce falsely elevated vancomycin results. Inaccurate test results may result in inappropriate patient treatment". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0629-2011
Status: Terminated
Initiated: 2010-09-13
Posted: 2010-12-16
Terminated: 2011-06-22
Recalling firm: Abbott Medical
Product: ARCHITECT iVancomycin Reagent; an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA; list 1P30-25 The ARCHITECT iVancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT i Vancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy.
Product code: DLJ Calibrators, Drug Specific
Reason for recall: The assay may produce falsely elevated vancomycin results. Inaccurate test results may result in inappropriate patient treatment.
FDA root cause: Other
Action: Abbott Laboratories issued a Product Correction letters dated September 13 and 15, 2010 to all customers that received ARCHITECT iVancomycin reagents in the last 12 months. In the September 13, 2010 letter, the accounts were informed of the falsely elevated results and were instructed to continue to follow all sample handling instruction in the package insert and to take the following additional actions to mitigate the risk of obtaining an incorrect result: 1. After following the primary tube manufacturer's recommended centrifugation instructions transfer serum or plasma for all specimens to a microcentrifuge tube for centrifugation at 150,000-300,000 g-minutes, following centrifugation guidelines in the chart in the letter. 2. Prior to testing, transfer the serum or plasma to a sample cup or secondary tube for testing. Care must be taken to transfer only the clarified specimen and not the lipemic material or pellet. The accounts were also requested to complete and fax back to Abbott the enclosed customer reply sheet, acknowledging the receipt and understanding of the recall. On September 15, 2010, Abbott discovered that the calculation for the determination of RCF (xg) given in the September 13, 2010 letter was incorrect. Incorrect Calculation previously provided: Relative Centrifugal Force (RCF) = 0.0000118 x rotational radius in centimeters x RPM2 Correct Calculation within revised letter: Relative Centrifugal Force (RCF) = 0.00001118 x rotational radius in centimeters x RPM2 Abbott stopped distribution of the previous letter and initiated redistribution of the revised letter to all impacted customers, globally, on September 15, 2010. Additionally, all customers which had already received the initial letter were sent a cover letter identifying the error. Customers can contact Abbott at 1-877-422688 about this action.
Quantity in commerce: 2,411 kits
Distribution: Worldwide Distribution: Throughout USA, including Puerto Rico, and the countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Oman, Pakistan, Poland, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom and Vietnam.
Product codes and lots: list 1P30-25, all lots

Product code DLJ

K072036Class IIArchitect Ivancomycin Reagents and Architect Ivancomycin Calibrators, Models: 1P30-25 and 1P30-01Biokit, S.A. / cleared 2008-03-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)