Device recall: Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 -…

Class II FDA enforcement event 85037. Recall start date: 13 Feb 2020. Status in the FDA record: Terminated. Termination date: 23 Apr 2021.

Reason for recall, in the words of FDA

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

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 13 Feb 2020. The firm address in the FDA record is in Newark, DE. FDA put the recall in Class II. FDA event 85037 has 6 product records. The first FDA enforcement report date is 1 Apr 2020. The record gives the status Terminated, with the termination date 23 Apr 2021.

FDA enforcement report The 6 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.

Nationwide Foreign: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta,…

Recalling firm

Siemens Healthcare Diagnostics, Inc., Newark, DE.

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

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

Products

6 product records in the event.

FDA event 85037: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1536-2020	Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA Chemistry systems. Such measurements are useful…	577 US and OUS 2617	Class II	Terminated	1 Apr 2020
Z-1537-2020	Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 assay is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates using the…	2323 US and 8193 OUS	Class II	Terminated	1 Apr 2020
Z-1538-2020	ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA Chemistry systems. Such measurements are useful in the screening of liver…	1901 Us and 37349 OUS	Class II	Terminated	1 Apr 2020
Z-1539-2020	ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usage: ADVIA TBIL_2 is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma of adults and neonates on the ADVIA Chemistry systems. Measurement of total bilirubin, an…	5666 US and 52202 OUS	Class II	Terminated	1 Apr 2020
Z-1540-2020	Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10444957 Product Usage: Dimension TBI method for the clinical chemistry syst6em is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum and plasma. Dimension…	1639 US and 747 OUS	Class II	Terminated	1 Apr 2020
Z-1541-2020	Dimension Vista Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10445146 Product Usage: Dimension Vista TBIL method is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum and plasma on the Dimension Vista System.…	N/A	Class II	Terminated	1 Apr 2020

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 2020: 916
Share of these events in Class II: 93%
Product records in this event: 6Median 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-1536-2020The 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.

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Cite this page

Recall Register. FDA enforcement event 85037. https://recallregister.com/fda/ii/85037/. 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: Nationwide Foreign: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta,…
What quantity of product is in FDA event 85037?: The event has 6 product records. The first record gives this quantity: 577 US and OUS 2617
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2020 have the same class?: 93% of the 916 device events that started in 2020 are in Class II.