MicroScan Pos Combo Panels 29, 33, and 34, MicroScan Pos BP Combo Panel Type 20 (2019-03-20)

Starting date:

March 20, 2019

Posting date:

April 12, 2019

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-69538

Last updated: 2019-04-12

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  Reason
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  Affected products

Affected Products

1. MicroScan Pos Combo Panels 29, 33, and 34
2. MicroScan Pos BP Combo Panel Type 20

Reason

Beckman Coulter has confirmed customer reports of insufficient growth observed in growth well in overnight conventional gram-positive panel lots with quality control (QC) organism M. Luteus ATCC 49732. The expected result is growth.

The issue was traced to a subassembly used in the manufacturing of the affected panel lots.

Affected products