Z-0415-2007

ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number 08C89-01; Temperature Controller...

Name: Z-0415-2007 ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number 08C89-01; Temperature Controller...
Creator: Abbott Laboratories, Inc
Published: 2006-12-12
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-12-12 / Terminated

FDA source

Abbott Laboratories, Inc began a recall of ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number 08C89-01; Temperature Controller Board Part #78560-109; distributed by Abbott... on 2006-12-12. The reason FDA records is "The re-designed ARCHITECT Temperature Controller Board has been identified as being susceptible to electromagnetic interference (EMI) in the laboratory. This can cause a board reset condition, stopping temperature...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0415-2007
Status: Terminated
Initiated: 2006-12-12
Posted: 2007-02-07
Terminated: 2007-09-24
Recalling firm: Abbott Medical
Product: ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number 08C89-01; Temperature Controller Board Part #78560-109; distributed by Abbott Laboratories, Irving, TX.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The re-designed ARCHITECT Temperature Controller Board has been identified as being susceptible to electromagnetic interference (EMI) in the laboratory. This can cause a board reset condition, stopping temperature control function of the board. Situation does not stop analyzer operation and does not generate an error condition alerting operator when condition occurs.
FDA root cause: Other
Action: Firm contacted consignees by telephone and fax with instructions to verify proper functioning of the Temperature Controller Board starting December 13, 2006.
Quantity in commerce: 57 units.
Distribution: Worldwide, including USA, Argentina, Australia, Brazil, Canada, Chile, Columbia, Dominican Republic, Germany, Hong Kong, Jamaica, Japan, Korea, Mexico, New Zealand, Peru, Puerto Rico, Singapore, Taiwan, Thailand, Trinidad, Tobago, Uruguay, and Venezuela.
Product codes and lots: Serial numbers: 1202790, 1202804, 1202805, 1202806, 1202807, 1202808, 1202809, 1202810, 1202811, 1202812, 1202813, 1202814, 1202815, 1202816, 1202817, 1202818, 1202819, 1202820, 1202821, 1202822, 1202823, 1202824, 1202825, 1202826, 1202827, 1202828, 1202829, 1202830, 1202831, 1202832, 1202833, 1202834, 1202835, 1202836, 1202837, 1202838, 1202839, 1202840, 1202841, 1202842, 1202843, 1202844, 1202845, 1202846, 1202847, 1202848, 1202849, 1202850, 1202851, 1202852, 1202853, 1202854, 1202855, 1202856, 1202857, 1202858, 1202859.

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