—#155944

Product

Dimension Vista Protein 1 Control, PROT 1 CON L, Siemens Material Number (SMN) 10445919, Product Code KC715; IVD

FDA product code: CHN — Immunochemical, Ceruloplasmin
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K083463
Affected lot / code info: Lot numbers: 6BQL01, 6BQL01A, 6BQL01B, 6BQL01C, 6BQL01D (exp. date 2017-06-13); 6JQL01A, 6JQL01B, 6JQL01C (exp. date 2018-01-31). --- Lot # (UDI): 6BQL01 (008427680063336BQL0120170613), 6BQL01A (008427680063406BQM01A20170617), 6BQL01B (008427680063406BQM01B20170617), 6BQL01C (008427680063406BQM01C20170617), 6BQL01D (008427680063406BQM01D20170617), 6JQL01A (008427680063336JQL01A20180131), 6JQL01B (008427680063336JQL01B20180131), 6JQL01C (008427680063336JQL01C20180131).

Why it was recalled

Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for ceruloplasmin (CER).

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Siemens issued an Urgent Medical Device Correction (UMDC) letter (PP-17-012.A.US, dated May 23, 2017) to US customers on May 23, 2017 and an Urgent Field Safety Notice (UFSN) to customers Outside the US in May 2017. Customers were instructed in the letter to use re-assigned CER values for the lots indicated of PROT1 CAL and PROT1 CON L, M, and H. In the US, the method of distribution is FEDEX and outside the US, the distribution is determined at the country level. Customers were requested to complete Effectiveness Check questionnaire attached to the UMDC/UFSN and return to Siemens within 30 days.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: Worldwide Distribution - US (nationwide) Internationally to Austria, Australia, Belgium, Canada, France, Germany, Great Britain, Italy, Japan, Netherlands, Portugal, Slovakia, Spain, Switzerland and Republic of Korea South

Timeline

Recall initiated: 2017-05-23
Terminated: 2018-03-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155944. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.