Z-0153-2014Class II

ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automated chemistry...

Name: Z-0153-2014 ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automated chemistry...
Creator: Beckman Coulter Inc.
Published: 2013-09-09
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-09-09 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples on 2013-09-09. FDA classified it as Class II and gives the reason as "The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure can be detected by...". 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-0153-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-09
Posted: 2013-11-05
Terminated: 2014-09-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit. If air bubbles are present, accuracy of the ISE test results may be affected.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: A customer notification letter dated 9/9/13 was sent to customers who received the ISE REF Valve, Part Number MU3226 for the AU400, AU640, AU2700, AU5400 and the ISE REF Valve, Part Number MU7638 for the AU480, AU680, AU5800 Chemistry Analyzers. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Beckman Coulter Customer Support Center via http://www.beckmancoulter.com/customersupport/support, via phone at (800) 854-3633 in the US and Canada. Outside of the US and Canada, customers are instructed to contact their local Beckman Coulter Representative.
Quantity in commerce: 4584 units total (1173 units in US)
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Canada, Vietnam, Zambia, and Zimbabwe.
Product codes and lots: AU480, Item Code: N3151200 N3151300 N3151400 N3151500 N3151600 N3151700 N3151800 N3151900 N3659600 N3659700 N3659900 N3660000 N3660200 N3660400 N3660600 N3660800 N3912500 AU480 OPA, Item Code: B11803 N3152300 N3152400 N3152500 N3152600 N3912600 AU680, Item Code: B12184 B12185 B12187 B12188 N3147100 N3147200 N3147300 N3147400 N3147500 N3148100 N3149800 N3153300 N3153700 N3153800 N3154000 N3658100 N3662100 N3662200 N3662400 N3662900 N3663000 N3910100 N3910400 N3910500 N3910800 N3910900 N3911200 N3911300 N3911900 AU680 OPA: B11474 N3148300 N3148600 N3148700 N3150500 N3912700 AU5800 OPA, Item Code: A94927 A94928 A94929 A94930 N9028030

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0153-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0152-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-05
Z-0153-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-05

Product code JJE

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)