Z-0795-03

ARCHITECT i System External Waste Pump

Name: Z-0795-03 ARCHITECT i System External Waste Pump
Creator: Abbott Laboratories, Inc
Published: 2003-01-27
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-01-27 / Terminated

FDA source

Abbott Laboratories, Inc began a recall of ARCHITECT i System External Waste Pump on 2003-01-27. The reason FDA records is "External waste pump has metal edge around perimeter sharp enough to cause scratch or cut". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0795-03
Status: Terminated
Initiated: 2003-01-27
Posted: 2003-05-09
Terminated: 2004-04-07
Recalling firm: Abbott Medical
Product: ARCHITECT i System External Waste Pump
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: External waste pump has metal edge around perimeter sharp enough to cause scratch or cut.
FDA root cause: Other
Action: Firm sent 01/27/2003 letter to all consingees informing them of the issue. US Cutomer Reply form will be distributed with the customer letter.
Quantity in commerce: 1318 units
Distribution: Nationwide and to the following foreign countries: Mexico, Chilie, Columbia, Dominican Republic, Hong Kong, Guatemala, Argentina, Canada, Australia, Venezuela, Brazil, Germany, New Zealand, Malaysia, Japan, Taiwan, Korea, Singapore, Thailand
Product codes and lots: Product List Number 8C94-99, no lot numbers or codes

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)