ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20… recallZ-1538-2020 · Siemens Healthcare Diagnostics, Inc. · initiated Feb 13, 2020

Why it was recalled

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

FDA root cause category: Under Investigation by firm

What the company is doing

Siemens Healthineers issued Urgent Medical Device Correction (UMDC # ACHC-20-02.A.US, ACHC-20-02.A.US.AC, ACHC-20-02.A.US.DM, ACHC-20-02.A.US.DV) and Urgent Field Safety Notice (UFSN # ACHC-20-02.A.OUS, ACHC-20-02.A.OUS.AC, ACHC-20-02.A.OUS.DM, ACHC-20-02.A.OUS.DV) on February 13, 2020 to all Atellica CH, ADVIA CH, Dimension, and Dimension Vista customers to inform them of the issue, the potential risk to health, and actions to be taken by the customer. Customers were instructed to:Review the information on eltrombopag interference (ADVIA CH and Atellica CH bilirubins) or use of total bilirubin assay is not recommended for patients on eltrombopag therapy (Dimension and Dimension Vista). Review the letter with their Medical Director Complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days. If they have received any complaints of illness or adverse events associated with the product, immediately contact their local Siemens Customer Care Center or their local Siemens Technical Support Representative.

Recall details

Recall number

Z-1538-2020

Status

Terminated

Initiated by the company

Feb 13, 2020

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Quantity

1901 Us and 37349 OUS

Product code

JFM

FDA submissions

K053132

Distribution

Nationwide Foreign: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom, Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Azerbaijan, Bahamas, Bahrain, Bangladesh, Benin, Bosnia Herzegovina, Botswana, Brazil, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Congo, Ecuador, Egypt, French Guinea, Georgia, Guadeloupe, Hong Kong, India, Indonesia, Iraq, Iran, Israel, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Lesotho, Libya, Macedonia, Malawi, Malaysia, Mali, Mexico, Montenegro, Morocco, Mozambique, Myanmar, New Zealand, Nigeria, Oman, Pakistan, Peru, Philippines, Qatar, Republic if Yemen, Republic Korea, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, South Africa, Swaziland, Taiwan, Tanzania, Thailand, Tunisia, Turkmenistan, United Arab Emirates, Ukraine, Uruguay, Venezuela, Vietnam, Zimbabwe

Product description

ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice. In vitro Diagnostic for the determination of direct bilirubin.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• ADVIA® Chemistry Direct Bilirubin_2 DBIL_2 Reagents 10341114

  Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, BILIRUBIN
  1 recall0 reports
• ADVIA® Chemistry DBIL_2 Direct Bilirubin 2 Reagents 10316610

  Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, BILIRUBIN
  1 recall0 reports

Other devices under the same FDA submission

1 device cleared under K053132 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• Atellica CH DBil_2 11097532

  Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, BILIRUBIN
  1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 85037).

• Z-1536-2020 · Terminated
  Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in th…
• Z-1537-2020 · Terminated
  Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 assay is for in vitro diagnostic us…
• Z-1539-2020 · Terminated
  ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usage: ADVIA TBIL_2 is for in vitro diagnostic use in the quantitative determination o…
• Z-1540-2020 · Terminated
  Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10444957 Product Usage: Dimension TBI method for the clinic…
• Z-1541-2020 · Terminated
  Dimension Vista Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10445146 Product Usage: Dimension Vista TBIL method is…