Z-1659-2015Class II

Liquid Waste Bottle, Catalog#10291587. The Immulite 2000 systems are continuous random-access instruments...

Name: Z-1659-2015 Liquid Waste Bottle, Catalog#10291587. The Immulite 2000 systems are continuous random-access instruments...
Creator: Siemens Medical Solutions Diagnostics
Published: 2015-03-05
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-03-05 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions Diagnostics began a recall of Liquid Waste Bottle, Catalog#10291587. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These... on 2015-03-05. FDA classified it as Class II and gives the reason as "The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1659-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-05
Posted: 2015-05-23
Terminated: 2018-01-16
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Liquid Waste Bottle, Catalog#10291587. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens Healthcare Diagnostics sent an Urgent Device Correction Letter/Field Correction Effective Check Form dated 3/5/15 via FedEx to their affected customers.
Quantity in commerce: 231 bottles
Distribution: Worldwide Distribution.
Product codes and lots: (Liquid Waste Bottle) -Product Code/ Catalog #10291587

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1659-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1658-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-23
Z-1659-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-23
Z-1660-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-23
Z-1661-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-23
Z-1662-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-23
Z-1663-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-23

Product code JJE

K970277Class IIUridyltransferase Kit, 50 Hour (80-4000-13K)Astoria-Pacific, Inc. / cleared 1997-12-11

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)