Health product recall

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