Z-0165-2018Class II

ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77...

Name: Z-0165-2018 ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77...
Creator: Abbott Laboratories, Inc
Published: 2017-09-29
License: https://open.fda.gov/license/

Abbott Medical / initiated 2017-09-29 / Completed / root cause: design

FDA source

Abbott Laboratories, Inc began a recall of ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems on 2017-09-29. FDA classified it as Class II and gives the reason as "The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as design.

Recall record

Recall number: Z-0165-2018
Classification: Class II
Status: Completed
Initiated: 2017-09-29
Posted: 2017-11-21
Recalling firm: Abbott Medical
Product: ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector.
Root cause tag: design
FDA root cause: Component design/selection
Action: All worldwide ARCHITECT Clinical Chemistry System customers with impacted instruments will receive the Product Correction Letter dated, 9/29/17. A customer reply is requested from all affected consignees.
Quantity in commerce: 34 units
Distribution: Worldwide distribution to US, Canada, France, and Germany.
Product codes and lots: c400073, c400103, c400498, c400600, c400890, c400934, c400935, c401018, c401055, c401056, c401182, c401505, c401520, c401686, c401887, c460196, c460200, c460943, c461550, c803669, c803753, c1600144, c1600249, c1600251, c1600641, c1600720, c1600819, c1600859, c1600976, c1601350, c1601351

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0165-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0165-2018	Class II	Completed	Voluntary: Firm initiated	2017-11-29	2017-11-21
Z-0166-2018	Class II	Completed	Voluntary: Firm initiated	2017-11-29	2017-11-21

Product code JJE

K980367Class IIAeroset SystemAbbott Laboratories / cleared 1998-04-01

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)