Food, drugs, devices › Siemens Healthcare Diagnostics, Inc.

Device recall: Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitr

FDA enforcement event 79593 · Class II · initiated 30 Jan 2018 · status Terminated · terminated 16 May 2019

DeviceVoluntary: Firm initiated1 product recordNewark, DE

Siemens Healthcare Diagnostics, Inc. (Newark, DE) initiated this device recall on 30 Jan 2018; FDA lists 1 product record under event 79593, classified Class II.

FDA defines Class II as 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. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 16 May 2019. Initiation: voluntary: firm initiated. Siemens Healthcare Diagnostics, Inc. has 333 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Siemens Healthcare Diagnostics, Inc., Newark, DE.

Reason for recall

"May produce erroneously low results from specific well sets."

Distribution

"Worldwide Distribution - USA (nationwide) and to the following countries: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Japan, Norway, Portugal, Slovakia,…"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1540-2018	Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine on the Dimension Vista System.	6000	Class II	Terminated	9 May 2018

Context

92%of 2018 device events are Class II1,074 events that year

1product record in this eventfirm median: 1

333events on this register for the firm

Other enforcement events for 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

All 333 events for Siemens Healthcare Diagnostics, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "May produce erroneously low results from specific well sets."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is 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.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution - USA (nationwide) and to the following countries: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Japan, Norway, Portugal, Slovakia,…"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 16 May 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.