HumaMeter A1c Reagent Kit

Brief description of the problem (reason for recall)

Axim Nuclear and Oncology (Pty) Ltd is recalling Humameter A1c Reagent Kit as HUMAN GESELLSCHAFT FÜR BIOCHEMICA UND DIAGNOSTICA GMBH the manufacturer during routine testing of retained samples, observed that the cartridges [CART] included in the above-mentioned products do not consistently meet the 90-day in-use stability specification on at 18-25 °C. After further investigation it turns out that cartridges [CART], which were stored at 18-25 °C for more than 7 days, may not reliably distinguish between results of 50 and 60mmol/mol and can lead to falsely low patient results with a mean deviation on of up to -7.87% from European Reference Laboratory target values. Thus, the storage and stability stated in the instruction on for use (IFU) is no longer valid.

The following original statement [CART] can be stored at 18-25 °C for up to 3 months. is hereby replaced by: [CART] can be stored at 18-25 °C for up to 7 days. Reagent kits, which were permanently stored at 2 °C to 8 °C, did not show any decrease in results and show all results within specification within the stated shelf life.

For kits, which were stored at 18-25 °C for more than 7 days, falsely low HbA1c patient results could prevent the physician from adjusting therapy. Because HbA1c results are interpreted alongside other clinical information and are normally repeated at routine intervals, the expected consequence is a delay in therapy adjustment un l the next review rather than an immediate risk to the patient. This risk is significantly higher for pa ents treated with oral medica on and/or noninsulin injectable alone, as regular (self-) monitoring of the blood glucose level is not recommended for this group

Advice for health professionals and distributors:

1. Read the Field Safety Notification, and return impacted stock to Axim N&O (Pty) Ltd
2. Complete and return Customer Notification Acknowledgment form, to Axim Nuclear and Oncology (Pty) by emailing to: E-mail: regulatoryaximnuc@axim.co.za

Follow-up Communication

Where necessary a follow-up communication shall be sent to those who failed to respond to the initial Field Safety Notification Communication.

AXIM NUCLEAR AND ONCOLOGY (PTY) LTD contact telephone number and email address:

Tel: +27 11 314 0140

Fax: +27 11 314 0141

E-mail: regulatoryaximnuc@axim.co.za

Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points, and the recall process was initiated.