Arkray SPOTCHEM II Glucose Reagent Test Strips Recalled for Inaccurate Results
Arkray Factory USA, Inc. is recalling SPOTCHEM II Glucose Reagent Test Strips because a lowered reaction rate causes inaccurate high glucose readings.
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: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. The affected lots will display a result of…"
Plain-English summary
Arkray Factory USA, Inc. is recalling one lot of SPOTCHEM II Glucose Reagent Test Strips (Item No. 77101, MEDTEST DX Catalog # 77424) and one lot of SPOTCHEM II Basic PANEL-1 Reagent Test Strips. The recall is due to a lowered reaction rate in the glucose reagent pad. The affected lot number is EA4M78. The product is used for the in vitro quantitative determination of glucose in human plasma from whole blood samples.
The defect causes the test strips to display a result of approximately 300 to 400 mg/dL for any glucose value that exceeds the upper limit of 416 mg/dL. This means that patients with very high blood glucose levels may receive a falsely low reading, which could impact clinical decision-making.
The affected units were distributed in the states of Florida, Illinois, Kentucky, Michigan, North Carolina, New York, Ohio, and Tennessee. A total of 88 boxes (25 foil packaged test strips per box) are involved. Healthcare providers and patients should stop using the affected test strips and contact Arkray Factory USA, Inc. for further instructions.
The recalled product
- Product
- arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitative determination of glucose in human plasma from whole blood samples.
- Manufacturer
- Arkray Factory USA, Inc.
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 (1)
- Lot Number EA4M78
Distribution
Part of a larger recall action
This product is one of 2 recalled by Arkray Factory USA, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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