—#162476

Product

ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500 tests)

FDA product code: NBC — Test, Natriuretic Peptide
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K031038
Affected lot / code info: Lot Numbers ending in: 192,193,196

Why it was recalled

In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with Multi-Diluent 15 and certain lots of BNP and TSH3RUL Assays.

Root cause (FDA determination)

Device Design

Action the firm took

Consignees are asked to return the response form and follow the instructions pertaining to their system and assays: Actions for ALL ADVIA Centaur Systems: Do not perform onboard dilutions on any ADVIA Centaur system if any of the affected kits are present on the system. Onboard dilutions for the ADVIA Centaur BNP and/or TSH3UL assay(s) are only supported when using ADVIA Centaur BNP kit lots ending in 210 and above and ADVIA Centaur TSH3UL kit lots ending in 310 and above. Actions for ADVIA Centaur XPT system: If you intend to perform onboard dilutions for the ADVIA Centaur BNP and/or TSH3UL assays, you must restart the workstation after scanning the master curve card for the BNP and/or TSH3UL assay kit lot, before ordering an onboard dilution for these assays. Please perform the attached steps to restart the workstation. Actions for ADVIA Centaur CP system: If any of the affected kit lots have been in use on the system, you must manually track the time that the Multi-Diluent 15 has been in use on board the system. Replace the ancillary pack of Multi-Diluent 15 every 7 days when used, until a follow-up communication is received from Siemens stating this issue has been resolved.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern: Distributed in the following U.S. states: AL, CA, DE, GA, IA, IL, IN, KY, MA, MI, MS, MT, NC, ND, NJ, NM, NV, NY, OH, PA, RI, TN, TX, VA, WA, WV, WY and Puerto Rico. Distributed in the following OUS countries: Australia Belgium¿¿¿¿¿¿¿¿ Canada Chile France¿¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Israel Italy¿¿¿¿¿¿¿¿¿¿ Japan Latvia¿¿¿¿¿¿¿¿¿ Luxembourg¿¿¿¿¿ Netherlands¿¿¿¿ New Zealand Norway¿¿¿¿¿¿¿¿¿ Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Romania¿¿¿¿¿¿¿¿ Singapore Slovakia¿¿¿¿¿¿¿ South Africa Spain¿¿¿¿¿¿¿¿¿¿ Switzerland¿¿¿¿ U.A.E.¿¿¿¿¿¿¿¿¿ United¿Kingdom¿

Timeline

Recall initiated: 2017-12-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162476. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.