—#130717

Product

ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: Cat No. 02816138/SMN 10309044 (100 test) 02816634/SMN 10309045 (500 test)

FDA product code: NBC — Test, Natriuretic Peptide
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K031038
Affected lot / code info: Lot 038174: 100 Test - 43305174 and 43278174; 500 Test - 43306174 and 43279174.

Why it was recalled

Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Centaur Systems BNP reagent contains an ADVIA Centaur Systems FT4 human-readable side label.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

A Customer Notification (CN) was sent to all affected Siemens Healthcare Diagnostics customers in the United States on October 03, 2014 to be delivered to customers on October 06, 2014 via Federal Express. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on October 06, 2014. These notices inform the customer of the potential to receive an ADVIA Centaur BNP ReadyPack with a FT4 human-readable side label. Siemens instructs customers to inspect their inventory and discard any BNP Readypacks with a FT4 side label. In addition, Siemens informs customers the end labels of the affected ReadyPacks correctly identify the pack as BNP and Siemens has confirmed the reagent within these packs is BNP Reagent. Therefore valid BNP results will be generated when calibrating and running quality control or patient samples. Fax-back forms will be used to confirm that the customers received the notification. For those customers that do not return a fax-back form, a Siemens representative will follow up with those customers to ensure they received the Customer Notification and completed the required actions.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide including Puerto Rico; and countries of: Canada, Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Fren.Polynesia, Germany, Great Britain, Greece, Guadeloupe, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Reunion, Russian Fed., Slovakia, Slovenia, Spain, Switzerland, Turkey, Unit.Arab Emir., AR, AU, BR, CL, CN, CR, IN, JP, KR, LK, MY, SG, TW, UY, VN, and ZA.

Timeline

Recall initiated: 2014-10-06
Posted by FDA: 2014-11-19
Terminated: 2015-07-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130717. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.