Reported Sep 26, 2012 · Terminated
ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B…
Siemens Healthcare Diagnostics, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc · 333 Coney St · East Walpole, MA · 02032-1516
Is this the product you have?
- ADVIA Centaur Prolactin AssayADVIA Centaur Calibrator B Catalog Number
- Prolactin110757
- and 110758US:Calibrator B 00652707 (6
- pack) or 00649625 (2 pack ) OUS2
- pack REF00650577
- and Ref00654130 (6
- pack) Product UsageADVIA
- Centaur CP Prolactin assayFor in vitro diagnostic use in the quantitative determination of prolactin in serum using the ADVIA Centaur System
- ADVIA Centaur Calibrator BFor in vitro diagnostic use in calibrating the following assays using ADVIA Centaur¿
- SystemsDigoxin, FSH, TotallgE, LH, LH2, Prolactin, Total hCG, and TSH
- Lot codes and dates
6 of 6 products
Products covered by this recall Model / number Product as published 00649625— 00652707Lot 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) — 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) 0065425479714A30 Exp Date Dec 2, 2012 82370A30 84274A30 85512E30 OUS: 2 pack 0065057778319A29 Exp Dec 2, 2102 78487A29 79024A29 79403A29 79770B29 79981B29 82935B29 85735C29 00654130 00654130(6 pack) 78321A29 Exp Dec 2,2102 79197A29 83314C29 - Amount recalled
- 15, 455 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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