Health product recall

Atellica CH Total Bilirubin_2 & Direct Bilirubin 2 (2020-02-12)

Starting date:
February 12, 2020
Posting date:
May 1, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-72917



Last updated: 2020-05-01

Affected Products

A. Atellica CH Total Bilirubin_2

B. Atellica CH Direct Bilirubin 2

Reason

Siemens Healthcare Diagnostics has become aware that the United Kingdom Medicines and Healthcare Products Regulatory Agency published an alert to healthcare professionals informing them that laboratory tests for bilirubin should be monitored for patients who take the drug eltrombopag due to the potential for discordant results.

Affected products

A. Atellica CH Total Bilirubin_2

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 2188064
  • 2189346
  • 11097531
Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave

Tarrytown

10591

New York

UNITED STATES


B. Atellica CH Direct Bilirubin 2

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 2188390
  • 2189494
  • 11097532
Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave

Tarrytown

10591

New York

UNITED STATES