Health product recall

BD MAX TNA MMK (SPC) (2018-05-04)

Starting date:
May 4, 2018
Posting date:
June 22, 2018
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-67066

Affected products

BD MAX TNA MMK (SPC)

Reason

Through internal testing BD has determined that an enzyme used in the production of the dried PCR Master Mix reagent included in specific lots is not meeting performance expectations throughout its shelf life. Data indicate that enzyme residual activity may appear above expected levels.

Affected products

BD MAX TNA MMK (SPC)

Lot or serial number
  • 6301777
  • 7016698
  • 7257844
  • 7269536
Model or catalog number

442830

Companies
Manufacturer

Geneohm Sciences Canada, Inc.,

2555 Boul. Du Parc Technologique,

Québec

G1P 4S5

Quebec

CANADA