CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report
Immulite ¿ 2000/Immulite ¿ 2000 XPi Gastrin recalled
Siemens Healthcare Diagnostics is recalling Immulite ¿ 2000/Immulite ¿ 2000 XPi Gastrin, distributed nationwide in the US. The recall was initiated on 2 Jan 2018 and the FDA has classified it as Class II.
Check your package
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-1681-2018
- FDA event ID
- 79505
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Jan 2018
- FDA classified
- 4 May 2018
- Reported
- 16 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 2 Jan 2018 | Recall initiated by company | |
| 4 May 2018 | Classified by FDA | +122 days |
| 16 May 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Gastrin
Where it was distributed
Nationwide and Canada, Mexico, and Thailand
Questions about this recall
Why was it recalled?
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
Which lots are affected?
Gastrin, Gastrin (IMMULITE/IMMULITE 1000, LKGA1), (IMMULITE 2000/IMMULITE 2000 XPi, LKGA2) Lot codes: 251 252 253 254 255
Where was it sold?
Nationwide and Canada, Mexico, and Thailand
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.
Other products in this recall event
23 other products · FDA event 79505This product is part of a recall event; the main page for the event is Immulite ¿ 2000/Immulite ¿ 2000 XPi Br-ma (CA15-3) recalled.
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