Medical device manufacturer and distributor, Beckman Coulter, has issued a medical device safety alert concerning its IMMAGE Immunochemistry Systems Immunoglobulin M (IGM) Reagent. The affected devices are identified as the following:

• Part Number: 447610
• Lot Number (Expiry Date): M803185 (30-Apr-2020) and M806164 (31-Jul-2020)

Patient samples tested with IGM reagent lots M803185 and M806164 may generate E60 (No Reaction, Antigen Excess Failed) or E66 (Unstable Reaction) error messages on very low concentration samples.

According to the manufacturer, samples at or near 4.2 mg/dL may generate E60 or E66 error messages without producing a result. There is no impact to patient sample results that are generated with no error messages.

Affected users are advised to discontinue use and discard IGM reagent lots M803185 and M806164 following their laboratory's disposal protocol.

The manufacturer is working to resolve the issue. Product replacement is on-going.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 2 May 2019