United StatesAIDBAG first aid kits that include the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System are affected; specific kit identifiers are REF/UDI‑DI/Lot 85-4661/00842209132089/85-4661122024 and 85-4742/00842209133536/85-4742123024, and the meter UDI‑DI is 20612479197217 (all lots). They were recalled because the meter can display an E-5 error code for a very high blood glucose event (>600 mg/dL) or for a test strip error, which can confuse operators and delay appropriate treatment.
What's being recalled
AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at the point-of-injury / point-of-illness. The original manufacturer labeling, including single use indications, is maintained for each device, which may be used independently and at different times. These specific kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that were recalled as part of RES 98317 with (510(k): K140100).
Recalling firm: North American Rescue LLC., Greer, SC, United States.
How to identify it
Kit REF/UDI-DI/Lot: 85-4661/00842209132089/85-4661122024; 85-4742/00842209133536/85-4742123024. Meter: UDI-DI: 20612479197217, all lots.
The hazard
Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the meter displays an E-5 error code for a very high blood glucose event (> 600 mg/dL) or when there is a test strip error, which can lead to operator confusion when evaluating patients and a delay in appropriate treatment. This is a downstream recall of Trividia Health Class I, Recall Event ID 98317.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US: CA, WA
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)