AIDBAG First Aid Kits with Recalled Blood Glucose Meters Recalled
North American Rescue LLC. is recalling AIDBAG first aid kits containing McKesson TRUE Metrix PRO blood glucose meters that display an E-5 error code incorrectly, potentially delaying appropriate patient treatment.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is a downstream FDA Class I recall (as stated in the source text). Per the rubric, FDA Class I recalls cannot score below 4. The defect presents a risk of delayed appropriate treatment due to operator confusion interpreting error codes on a critical patient-monitoring device.
Plain-English summary
North American Rescue LLC. is recalling AIDBAG first aid kits because they contain McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose Systems that were subject to a Class I recall. The meters have a software design issue where the E-5 error code is displayed both for very high blood glucose events (greater than 600 mg/dL) and for test strip errors.
This ambiguity in the error display can cause operator confusion when evaluating patients, potentially leading to a delay in appropriate treatment. The affected kits include two kit numbers: 85-4661 (UDI-DI 00842209132089) and 85-4742 (UDI-DI 00842209133536), along with all lots of the individual glucose meter (UDI-DI 20612479197217). The kits were distributed in California and Washington.
Patients and healthcare providers who have received these kits should be aware of the E-5 error code ambiguity. Consult the device's instructions for use and the original manufacturer labeling for each individual device to understand appropriate action when an E-5 error is displayed. Users should verify whether an E-5 error indicates a blood glucose reading above 600 mg/dL or a test strip issue before making clinical decisions.
The recalled product
- Product
- 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…
- Manufacturer
- North American Rescue LLC.
- Affected units
- 21
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Kit REF/UDI-DI/Lot: 85-4661/00842209132089/85-4661122024
- 85-4742/00842209133536/85-4742123024. Meter: UDI-DI: 20612479197217
- all lots.
Distribution
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