HemoCue AB: The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the measured whole blood glucose value by a

Hazard

Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency, and purity of the product. This failure could increase the probability of an incorrect test result or a delayed test result.

Details from the source

Reason for recall: Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency, and purity of the product. This failure could increase the probability of an incorrect test result or a delayed test result. Distribution: US Nationwide distribution in the state of AR. Quantity: 4 Boxes Lot/code info: UDI-DI: 07311091107060, Lot: 2501708 (Only 4 boxes within specific McKesson Shipment)

UPC codes

07311091107060

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.