ADVIA Chemistry System-LIPASE (LIP) Assay (2019-12-23)
- Starting date:
- December 23, 2019
- Posting date:
- January 20, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-72121
Last updated: 2020-01-21
Affected Products
ADVIA Chemistry System-LIPASE (LIP) Assay
Reason
Siemens Healthcare Diagnostics, Inc. has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using ADVIA Chemistry Lipase reagent lot 485700. Preliminary investigation has indicated that not all cartons within this reagent lot are impacted.
Affected products
ADVIA Chemistry System-LIPASE (LIP) Assay
Lot or serial number
485700
Model or catalog number
B01-4840-01
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES