Recall Z-2409-2012— Siemens Healthcare Diagnostics, Inc
Class III · Terminated
Class III FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2012-08-07, terminated 2014-02-26. It names one FDA 510(k) clearance: K904714. Product: 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. Reason: ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2012-08-07
- Terminated
- 2014-02-26
- Firm location
- East Walpole, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40
Data sourced from openFDA. This site is unofficial and independent of the FDA.