Device recall: Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test 02816138 10309045, 10309044 028…

Class II FDA enforcement event 63682. Recall start date: 14 Nov 2012. Status in the FDA record: Terminated. Termination date: 25 Sep 2015.

Reason for recall, in the words of FDA

Operating range of the ADVIA Centaur systems is 18°C to 30°C (64.4°F to 86.0°F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Siemens Healthcare Diagnostics, Inc started this device recall on 14 Nov 2012. The firm address in the FDA record is in East Walpole, MA. FDA put the recall in Class II. FDA event 63682 has 7 product records. The first FDA enforcement report date is 19 Dec 2012. The record gives the status Terminated, with the termination date 25 Sep 2015.

FDA enforcement report The 7 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution - USA (nationwide) and Internationally to the following countries: Argentina Australia Austria Azerbaijan Belgium Bosnia Herzeg. Brazil Canada Chile COLOMBIA Croatia Czech…

Recalling firm

Siemens Healthcare Diagnostics, Inc, East Walpole, MA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

7 product records in the event.

FDA event 63682: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0506-2013	Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test 02816138 10309045, 10309044 028 Intended Use For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is…	100 test=24291 and 500 test= 9679	Class II	Terminated	19 Dec 2012
Z-0507-2013	Siemens Healthcare BR Assay for CA 27.29 250 Test Kits 03896216 50 Test Kit 02419937 Ref Kit (US only) 10340081 Intended Use The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur and ADVIA Centaur XP…	250 test =1678 and 50 test =2660 and Ref. 1196	Class II	Terminated	19 Dec 2012
Z-0508-2013	Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379 Intended Use The ADVIA Centaur CA 19-9 Assay is an in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is indicated…	250 test=525 and 50 test=12243	Class II	Terminated	19 Dec 2012
Z-0509-2013	Siemens Healthcare ADVIA Centaur DHEA-504 (DHEAS) 50 Test 06489701 The ADVIA Centaur DHEAS assay is an in vitro diagnostic immunoassay for the quantitative determination of dehydroepiandrosterone sulfate (DHEAS) in human serum and plasma using the ADVIA Centaur and ADVIA Centaur XP systems	12976	Class II	Terminated	19 Dec 2012
Z-0510-2013	Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968 Intended Use For in vitro diagnostic use in the quantitative determination of digitoxin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems.	50 test=792 and 250 test=525	Class II	Terminated	19 Dec 2012
Z-0511-2013	Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref Kit (US only) 09132781 Ref Kit (US only) 00203473 Intended Use For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the ADVIA Centaur and ADVIA Centaur XP systems.	100 Test=27392; 500 test=21045 and Reference Kits=3773	Class II	Terminated	19 Dec 2012
Z-0512-2013	Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02) 250 Test 08838753 50 Test 03009619 Intended Use For in vitro diagnostic use in the quantitative determination of theophylline in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems.	50 test=2397 and 250 test= 594	Class II	Terminated	19 Dec 2012

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2012: 823
Share of these events in Class II: 88%
Product records in this event: 7Median of the firm: 1
Events of the firm on the register: 333

Other events of the firm

Other FDA enforcement events of Siemens Healthcare Diagnostics, Inc
Initiated	Product (first record)	Type	Class	Records
13 Jul 2026	Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL	Device	Class II	2
6 Jul 2026	Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic	Device	Class II	1
26 Jun 2026	Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL	Device	Class III	1
26 Jun 2026	Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL	Device	Class III	1
8 Jun 2026	Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.	Device	Class II	1
7 May 2026	Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay	Device	Class II	1
2 Apr 2026	epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;	Device	Class II	1
18 Mar 2026	Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.	Device	Class II	1
23 Feb 2026	Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;	Device	Class II	1
20 Jan 2026	Atellica CH Urine Albumin (UAlb). Material Number: 11537225	Device	Class II	1

Siemens Healthcare Diagnostics, Inc: all 333 events

Official channels

FDA enforcement report Z-0506-2013The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 63682. https://recallregister.com/fda/ii/63682/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution - USA (nationwide) and Internationally to the following countries: Argentina Australia Austria Azerbaijan Belgium Bosnia Herzeg. Brazil Canada Chile COLOMBIA Croatia Czech…
What quantity of product is in FDA event 63682?: The event has 7 product records. The first record gives this quantity: 100 test=24291 and 500 test= 9679
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2012 have the same class?: 88% of the 823 device events that started in 2012 are in Class II.