CLASS II Device recall · Reported 23 Nov 2016 · FDA Enforcement Report

Advia Centaur CA 19-9 Assay (50 test kit)-for use recalled

Siemens Healthcare Diagnostics is recalling Advia Centaur CA 19-9 Assay (50 test kit)-for use, with the Advia Centaur and Advia, distributed nationwide in the US. The recall was initiated on 19 Oct 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesKit lots ending in: 380 Exp Date 2016-10-21; 382/ 2017-01-09; 384 2017-02-06; 386 2017-03-24 ; 388 2017-05-14 ; 390 2017-06-12 . And all future lots until the issue is resolved. Siemens will also include a notecard in future lots of reagents referring customers to the communications .

Quantity recalled18,733 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0612-2017
FDA event ID: 75523
Recalling firm: Siemens Healthcare Diagnostics, East Walpole, MA
Classification: Class II
Status: Terminated
Recall initiated: 19 Oct 2016
FDA classified: 17 Nov 2016
Reported: 23 Nov 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

19 Oct 2016	Recall initiated by company
17 Nov 2016	Classified by FDA	+29 days
23 Nov 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the ADVIA Centaur/XP/XPT systems as stated in the Instructions for Use.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491379 In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT instrument. Siemens stated that the assay is being marketed on the XPT following FDAs Reagent Replacement Policy. Siemens plans to request CLIA Categorization for the CA19-9 assay on XPT the week of 11/21/2016.

Where it was distributed

Nationwide Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Germany, Great Britain, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Latvia, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uruguay, Vatican City, Vietnam

Nationwide

Questions about this recall

Why was it recalled?

CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the ADVIA Centaur/XP/XPT systems as stated in the Instructions for Use.

Which lots are affected?

Kit lots ending in: 380 Exp Date 2016-10-21; 382/ 2017-01-09; 384 2017-02-06; 386 2017-03-24 ; 388 2017-05-14 ; 390 2017-06-12 . And all future lots until the issue is resolved. Siemens will also include a notecard in future lots of reagents referring customers to the communications .

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 75523

Reported	Class	Recall	Company	Reason	Where
23 Nov 2016	CLASS II	Advia Centaur CA 19-9 Assay recalled by Siemens Healthcare Diagnostics	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide

More recalls from Siemens Healthcare Diagnostics

All 694

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	Syva EMIT 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
26 Aug 2026Device	CLASS II	Beckman Coulter, Emit 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
12 Aug 2026Device	CLASS III	Syva Emit Disopyramide Assay Enzyme Immunoassay recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
12 Aug 2026Device	CLASS II	Atellica CH Urine Albumin recalled by Siemens Healthcare Diagnostics	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
12 Aug 2026Device	CLASS III	Syva Emit tox Serum Tricyclic Antidepressant recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide

Other Test Kits & Diagnostics recalls

All 2,656

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	STA Staclot Protein recalled by Diagnostica Stago	Diagnostica Stago	Potency & Assay	Nationwide
26 Aug 2026Device	CLASS II	DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	Syva EMIT 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
26 Aug 2026Device	CLASS II	Beckman Coulter, Emit 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide