CLASS II Device recall · Reported 27 May 2015 · FDA Enforcement Report

Immulite/Immulite 1000 Systems Tbg recalled

Siemens Healthcare Diagnostics is recalling Immulite/Immulite 1000 Systems Tbg. The recall was initiated on 9 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLOT 0257, SMN 10381643

Quantity recalled155 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-1629-2015
FDA event ID: 71006
Recalling firm: Siemens Healthcare Diagnostics, Tarrytown, NY
Classification: Class II
Status: Terminated
Recall initiated: 9 Apr 2015
FDA classified: 19 May 2015
Reported: 27 May 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

9 Apr 2015	Recall initiated by company
19 May 2015	Classified by FDA	+40 days
27 May 2015	Published in enforcement report	+8 days

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

Reason for recall

IMMULITE/IMMULITE 1000 TBG catalog LKTB lot 257 is failing the adjustment slope instrument parameter of <1.80. The resulting slope of the kit is >1.80 resulting in the potential to produce depressed TBG patient values.

Product as listed by the FDA

IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum, as an aid in the diagnosis and treatment of thyroid diseases.

Where it was distributed

Worldwide Distribution to the countries of : Denmark, Spain, Great Britain, Germany, Bosnia Herzeg, China and Russian Federation.

Questions about this recall

Why was it recalled?

Which lots are affected?

LOT 0257, SMN 10381643

Where was it sold?

Worldwide Distribution to the countries of : Denmark, Spain, Great Britain, Germany, Bosnia Herzeg, China and Russian Federation.

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.

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 Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide