CLASS II Device recall · Reported 16 Mar 2016 · FDA Enforcement Report
Advia Centaur Calibrator E recalled by Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics is recalling Siemens Healthcare Diagnostics Advia Centaur Calibrator E, distributed nationwide in the US. The recall was initiated on 4 Feb 2016 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-1078-2016
- FDA event ID
- 73263
- Recalling firm
- Siemens Healthcare Diagnostics, East Walpole, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Feb 2016
- FDA classified
- 8 Mar 2016
- Reported
- 16 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 4 Feb 2016 | Recall initiated by company | |
| 8 Mar 2016 | Classified by FDA | +33 days |
| 16 Mar 2016 | 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
ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
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
Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 10321075 ADVIA Centaur¿ Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone. ADVIA Centaur¿ Testosterone For in vitro diagnostic use in the quantitative determination of total testosterone {bound and unbound) in serum using the ADVIA Centaur and ADVIA Centaur XP Systems
Where it was distributed
Worldwide Distribution US (nationwide) and Internationally to: Canada AR AU BD BR CA CH CL CN CO DO EC GT HK ID IE IL IN JP KR LK MM MX MY NI NP NZ PE PH PY SA SG TH TW UY VN ZA
Questions about this recall
Is Advia Centaur Calibrator E recalled?
Yes. Siemens Healthcare Diagnostics recalled Advia Centaur Calibrator E on 4 Feb 2016. The recall is Class II and its status is Terminated. Recall number Z-1078-2016.
Why was it recalled?
ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
Which lots are affected?
Lot code/ Exp.Date: 86344A42 May 9, 2016; 55437A42 May 9, 2016; 54801A42 May 9, 2016; 53651A42 May 9, 2016; 53625A42 May 9, 2016; 15610A43 November 27, 2016; 18375A43 November 27, 2016; 24990A43 November 27, 2016; 38988A43 November 27, 2016
Where was it sold?
Worldwide Distribution US (nationwide) and Internationally to: Canada AR AU BD BR CA CH CL CN CO DO EC GT HK ID IE IL IN JP KR LK MM MX MY NI NP NZ PE PH PY SA SG TH TW UY VN ZA
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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