Zym B Reagent, API NH Strip, API Listeria, and FB Reagent (2014-03-07)

Starting date:

March 7, 2014

Posting date:

April 4, 2014

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-38773

• 
  Reason
• 
  Affected products

Recalled Products

A. Zym B Reagent

B. API NH Strip

C. API Listeria

D. FB Reagent

Reason

During the stability sudy of a new batch of Zym B reagent (70493), a visual defect has been observed. After three month of stability, this batch presents an heterogeneous aspect of color from yellow to red (a color yellow to amber is considered as conform according to the package insert). This visual defect is due to a specific new batch of raw material (lot number MKBP5202V of Fast Blue BB Salt Sigma) used for the manufacturing of several batches of FB reagent and Zym B reagent. As the involved batches of Zym B reagent are included inside of API NH (10400) and API Listeria (10300) kits, the both references are also impacted.

Affected products