—#160060

Product

ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.

FDA product code: CHP — Radioimmunoassay, Estradiol
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K100293
Affected lot / code info: Lot Numbers: 00387A21, 16673A21, 36243A21; 00388A21, 15448A21, 51211A21; 20640A21; 51024A21. Expiration Date: 2018-03-08

Why it was recalled

Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems when calibrating with Calibrator 30 kit lots ending in 21 (C3021) as compared to Calibrator 30 kit lots ending in 20 (C3020).

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

An Urgent Medical Device Recall letter dated June 7, 2017 was distributed to all customers in the United States and an Urgent Field Safety Notice was distributed to all customers outside the United States who have received ADVIA Centaur Systems Calibrator 30 kit lot ending in 21(C3021). These letters instruct customers who operate the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems to discontinue use of C3021 . The letters inform customers that Calibrator 30 kit lots ending in 20 (C3020) and 23 (C3023) are not impacted and can be used. The letters inform customers who operate ADVIA Centaur CP systems to continue using their inventory of C3021, as they are not impacted by this issue. All affected domestic customers were sent a hard copy of the Urgent Medical Device Recall via Federal Express. Fax-back forms will be used to confirm that the customers received the Urgent Medical Device Recall letter.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc
Address: 333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

Distribution pattern: US and OUS.

Timeline

Recall initiated: 2017-06-07
Terminated: 2019-05-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #160060. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.