Z-0132-2010

ARCHITECT i2000 System and ARCHITECT i2000 SR wash buffer and wash zone mechanism grounding kit. ARCHITECT...

Name: Z-0132-2010 ARCHITECT i2000 System and ARCHITECT i2000 SR wash buffer and wash zone mechanism grounding kit. ARCHITECT...
Creator: Abbott Laboratories, Inc
Published: 2009-07-17
License: https://open.fda.gov/license/

Abbott Medical / initiated 2009-07-17 / Terminated

FDA source

Abbott Laboratories, Inc began a recall of ARCHITECT i2000 System and ARCHITECT i2000 SR wash buffer and wash zone mechanism grounding kit. ARCHITECT System is designed to perform automated chemistry... on 2009-07-17. The reason FDA records is "Under certain conditions, the product's wash buffer containing sodium azide can come in contact with the wash zone mechanism ground cables on either of the two wash zones. The copper in the ground strap may corrode and...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0132-2010
Status: Terminated
Initiated: 2009-07-17
Posted: 2009-11-09
Terminated: 2010-01-26
Recalling firm: Abbott Medical
Product: ARCHITECT i2000 System and ARCHITECT i2000 SR wash buffer and wash zone mechanism grounding kit. ARCHITECT System is designed to perform automated chemistry tests utilizing photometry and potentiometric technology; and immunoassay tests utilizing chemiluminescent microparticle assay detection technology.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Under certain conditions, the product's wash buffer containing sodium azide can come in contact with the wash zone mechanism ground cables on either of the two wash zones. The copper in the ground strap may corrode and form an unstable chemical substance (metal azide) that may be sensitive to direct pressure and impact.
FDA root cause: Other
Action: A product correction notice was issued to consignees on July 17, 2009. Field representatives were instructed to visit consignees, inspect cables and replace them
Quantity in commerce: 4,526
Distribution: Worldwide Distribution
Product codes and lots: ARCHITECT i2000 System List Number 8C89-01; ARCHITECT i2000SR System System List Number 3M74-01 and 3M74-02; Wash Zone Mechanism Grounding Kit Part Number 7-201369-01; Concentrated Wash Buffer 1 L List Number 6C54-58 and l0 L List number 6C54-88.

Product code JJE

K983212Class IAbbott Architect TestosteroneAbbott Laboratories / cleared 1998-11-18

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)