CLASS III Device recall · Reported 26 Sep 2012 · FDA Enforcement Report
Advia Centaur Prolactin Assay: Advia Centaur Calibrator B recalled
Siemens Healthcare Diagnostics is recalling Advia Centaur Prolactin Assay: Advia Centaur Calibrator B, distributed nationwide in the US. The recall was initiated on 7 Aug 2012 and the FDA has classified it as Class III.
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-2409-2012
- FDA event ID
- 62897
- Recalling firm
- Siemens Healthcare Diagnostics, East Walpole, MA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 Aug 2012
- FDA classified
- 20 Sep 2012
- Reported
- 26 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 7 Aug 2012 | Recall initiated by company | |
| 20 Sep 2012 | Classified by FDA | +44 days |
| 26 Sep 2012 | Published in enforcement report | +6 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 Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40
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
ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP Prolactin assay: For in vitro diagnostic use in the quantitative determination of prolactin in serum using the ADVIA Centaur System. ADVIA Centaur Calibrator B: For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur¿ Systems: Digoxin, FSH, TotallgE, LH, LH2, Prolactin, Total hCG, and TSH
Where it was distributed
Worldwide Distribution - US Nationwide and the countries of: Canada, Argentina, Australia, Bangaldesh,Brazil, Chile, China, Columbia, Croatia, Ecuduar, Egypt, Hong Kong, India, Israel,Japan, Korea, Maylasia, New Zealand, Mexico, Peru, Philipines, Pakistan, Saudia Arabia, Singapore, Thailand, Taiwan, Viet Nam, South Africa and UK.
Questions about this recall
Why was it recalled?
ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40
Which lots are affected?
US: 2 Pack Ref: 00649625: Lot Numbers/Exp Date: Dec 2, 2012: 78813A30 79982A30 81013A30 82021B30 82767B30 83453C30 85447D30 87319A40 Exp Date:April 9, 2013 85598A40 85708A40 86098A40 87319A40 87979B40 88809B40 89351C40 91750C40 (6 pack) Ref. 00652707: Lot Numbers/Exp Date: Dec 2 2012 79354A30 80802A30 81892B30 82815B30 83741D30 84186A40 Exp. Date April, 8, 2013 85599A40 86191A40 88102B40 89717C40 91383C40 (6 Pack) Ref: 00654254 79714A30 Exp Date Dec 2, 2012 82370A30 84274A30 85512E30 OUS: 2 pack REF: 00650577 78319A29 Exp Dec 2, 2102 78487A29 79024A29 79403A29 79770B29 79981B29 82935B29 85735C29 00654130 Ref: 00654130 (6 pack) 78321A29 Exp Dec 2,2102 79197A29 83314C29
Where was it sold?
Worldwide Distribution - US Nationwide and the countries of: Canada, Argentina, Australia, Bangaldesh,Brazil, Chile, China, Columbia, Croatia, Ecuduar, Egypt, Hong Kong, India, Israel,Japan, Korea, Maylasia, New Zealand, Mexico, Peru, Philipines, Pakistan, Saudia Arabia, Singapore, Thailand, Taiwan, Viet Nam, South Africa and UK.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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
1 other product · FDA event 62897| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Advia Centaur Fsh Assay: Advia Centaur Calibrator B US recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
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