SYNCHRON Systems Barbiturates (BARB) Reagent (2019-06-04)

Starting date:

June 4, 2019

Posting date:

June 28, 2019

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-70313

Last updated: 2019-06-28

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  Reason
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  Affected products

Affected Products

SYNCHRON Systems Barbiturates (BARB) Reagent

Reason

Studies indicate that cross-reactivity testing may not meet the claims indicated in the barbiturates chemistry information sheet (CIS).

The presence of the following compounds in urine may lead to false negative results:

• barbital at a concentration of 1500 to ~1700 ng/mL
• butabarbital at a concentration of 250 to ~300 ng/mL
• butalbital at a concentration of 400 to ~500 ng/mL
• diallybarbital at a concentration of 600 to ~700 ng/mL
• pentobarbital at a concentration of 500 to ~600 ng/mL
• phenobarbital at a concentration of 800 to ~900 ng/mL
• talbutal at a concentration of 80 to ~125 ng/mL

The presence of glutethimide in urine at a concentration of ~ 8 to 80 ng/mL may lead to false positive results.

Affected products