HemoCue glucose microcuvettes experienced transit time outside of specified limits
Four boxes of HemoCue Glucose 201 Microcuvettes are being recalled because transit time fell outside limits, so stability through the microcuvette lifetime can no longer be guaranteed.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall over a storage and transit excursion where stability can no longer be guaranteed, with no quantified performance failure stated.
Plain-English summary
HemoCue Glucose 201 Microcuvettes, UDI-DI 07311091107060, are being recalled. The microcuvettes are designed for use with the HemoCue Glucose 201 or DM Analyzer, and each box contains 4 vials of 25 microcuvettes. The action covers 4 boxes from lot 2501708, within a specific McKesson shipment.
According to the manufacturer, the 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. The FDA classified the action as Class II.
Distribution was nationwide in the United States, in the state of Arkansas.
Laboratories should identify affected stock using the UDI-DI and lot number above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- 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 factor of 1.112 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcu
- Manufacturer
- HemoCue AB
- Hazard
- storage-excursion
- transit-time
- stability
- class-ii
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 (2)
- UDI-DI: 07311091107060
- Lot: 2501708 (Only 4 boxes within specific McKesson Shipment)
Distribution
Distributed nationwide across the United States.
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