ACCESS SYSTEM & UNICEL DXI 600/800 ACCESS IMMUNOASSAY SYSTEM - UNCONJUGATED ESTRIOL ASSAY (2020-08-31)
- Starting date:
- August 31, 2020
- Posting date:
- September 18, 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-73925
Last updated:
2020-09-18
Affected Products
A. ACCESS SYSTEM - UNCONJUGATED ESTRIOL ASSAY
B. UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM - UNCONJUGATED ESTRIOL ASSAY
C. UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - UNCONJUGATED ESTRIOL ASSAY
Reason
Customer feedback has helped Beckman Coulter identify and characterize the potential for higher than expected Bovine-ALP associated interference in patient samples tested with the access uE3 assay, for the affected lots. An internal investigation of ~300 samples confirmed that up to 3% of patient samples may demonstrate Bovine-ALP associated interference. The frequency and mechanism of Bovine-ALP associated interference is specific to the access uE3 assay. This interference is not associated with patient sample endogenous ALP levels.
Based on the internal investigation performed on ~300 samples, Bovine-ALP associated interference could increase serum sample uE3 concentrations by:
- a mean of 50% (range 33%-77%) in samples with uE3 concentrations >1.5 ng/mL.
- a mean of 0.53 ng/mL (range 0.42-0.70 ng/mL) in samples with uE3 concentrations ?1.5 ng/mL.
A falsely elevated uE3 test result can lead to inaccurately classifying the relative risk of chromosomal anomalies-such as trisomy 21 and 18-in patient samples undergoing triple and quad prenatal screening.
Second trimester prenatal screening includes Alpha-fetoprotein (AFP), Human chorionic gonadotropin (hCG), unconjugated estriol (uE3) and inhibin A. Only uE3 is affected by the issue.
Affected products
A. ACCESS SYSTEM - UNCONJUGATED ESTRIOL ASSAY
Lot or serial number
- 921133
- 921348
- 921742
Model or catalog number
33570
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
B. UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM - UNCONJUGATED ESTRIOL ASSAY
Lot or serial number
- 921133
- 921348
- 921742
Model or catalog number
33570
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
C. UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - UNCONJUGATED ESTRIOL ASSAY
Lot or serial number
- 921133
- 921348
- 921742
Model or catalog number
33570
Companies
- Manufacturer
-
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES