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U.S. Department of Health and Human Services

Class 2 Device Recall HemoCue Glucose 201 Microcuvettes

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 Class 2 Device Recall HemoCue Glucose 201 Microcuvettessee related information
Date Initiated by FirmMay 12, 2025
Date PostedJuly 02, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2070-2025
Recall Event ID 97025
510(K)NumberK020935 
Product Classification Glucose oxidase, glucose - Product Code CGA
ProductThe 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 Microcuvettes are available in individual packages or in vials. The box contains 4 vials with 25 microcuvettes in each vial.
Code Information UDI-DI: 07311091107060, Lot: 2501708 (Only 4 boxes within specific McKesson Shipment)
FEI Number 3003044483
Recalling Firm/
Manufacturer		 HemoCue AB
Kuvettgatan 1
Angelholm Sweden
For Additional Information Contact
+46 431 48 1200
Manufacturer 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.
FDA Determined
Cause 2		Storage
ActionOn 5/14/2025 field notices were emailed to customers who were asked to do the following: 1) Ensure that the affected product at customer site has been destroyed according to local regulations. 2) Complete and return the Field Notice Verification Form. If you have any questions regarding this Field Notice, please send an e-mail to cuvettes@hemocue.com
Quantity in Commerce4 Boxes
DistributionUS Nationwide distribution in the state of AR.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = CGA
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