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Health product recall

MICROSCAN POS COMBO and POS BREAKPOINT COMBO (2015-11-23)

Starting date:
November 23, 2015
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-56214

Affected Products

  1. MICROSCAN POS COMBO
  2. MICROSCAN POS BREAKPOINT COMBO

Reason

Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with quality control (QC) american type culture collection (ATCC) organism staphylococcus aureus ATCC 29213 in the affected panels. The expected result is positive.
The falsely negative result was traced to a single VP component lot used in the manufacturing of the affected panels.

Affected products

A. MICROSCAN POS COMBO

Lot or serial number
  • 2016-04-29
  • 2016-04-30
  • 2016-05-04
  • 2016-05-05
Model or catalog number
  • B1016-161
  • B1017-201
  • B1017-211
      • Companies
      Manufacturer
      Beckman Coulter, Inc.
      250 S. Kraemer Blvd.
      Brea
      92821
      California
      UNITED STATES

B. MICROSCAN POS BREAKPOINT COMBO

Lot or serial number

2016-04-29
2016-04-30
2016-05-06

Model or catalog number

B1016-152
B1016-164
B1017-202
B1017-206
B1017-214

Companies
Manufacturer
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES

Date modified: