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Device recall: Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimu

FDA enforcement event 63852 · Class III · initiated 28 Nov 2012 · status Terminated · terminated 28 Oct 2013

DeviceVoluntary: Firm initiated3 product recordsTarrytown, NY

FDA enforcement event 63852 is a device recall by Siemens Healthcare Diagnostics of Tarrytown, NY, initiated 28 Nov 2012 and classified Class III, with 3 product records.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 6% of the 823 device enforcement events initiated in 2012 carry the same class.

Status: Terminated, terminated 28 Oct 2013. Initiation: voluntary: firm initiated. Siemens Healthcare Diagnostics has 17 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, Tarrytown, NY.

Reason for recall

"The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H)"

Distribution

"Worldwide Distribution - USA including CA, GA, IL, IN, MI, MN, NY, and Puerto Rico. Internationally to Agentina, Bolivia, Brazil, Canada, Chile, Guatemala, South Korea, Philippines, Paraguay,…"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0646-2013	Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.	Lot 969=33 units (29 units foreign) Lot 970=7 units (42 units foreign)	Class III	Terminated	16 Jan 2013
Z-0647-2013	Immunoradiometric assay.	Lot 831=19 units (all foreign consignees) and Lot 832=2 units (all foreign consignees)	Class III	Terminated	16 Jan 2013
Z-0648-2013	Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.	Lot 742= 8 units all foreign consignees) Lot 743=7 units (all foreign consignees)	Class III	Terminated	16 Jan 2013

Context

6%of 2012 device events are Class III823 events that year

3product records in this eventfirm median: 1

17events on this register for the firm

Other enforcement events for Siemens Healthcare Diagnostics

Initiated	Product (first record)	Type	Class	Records
17 Oct 2017	BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184	Device	Class II	1
19 Sep 2014	IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. For in vitro diagnostic use w	Device	Class II	1
19 Aug 2014	ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a labora	Device	Class II	2
13 Aug 2014	ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525,	Device	Class II	2
6 Aug 2014	ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Numbe	Device	Class II	1
18 Feb 2014	ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA Centaur XP	Device	Class II	1
20 Dec 2013	IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products	Device	Class II	2
20 Dec 2013	IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SMN 10381158, IVD, 100 test kit size --- Siem	Device	Class II	2
6 Nov 2013	IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380	Device	Class II	1
24 Sep 2013	Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SM	Device	Class II	1

All 17 events for Siemens Healthcare Diagnostics

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H)"

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution - USA including CA, GA, IL, IN, MI, MN, NY, and Puerto Rico. Internationally to Agentina, Bolivia, Brazil, Canada, Chile, Guatemala, South Korea, Philippines, Paraguay,…"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 28 Oct 2013. "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.