Arkray SPOTCHEM II Reagent Test Strips Recalled for Glucose Error
Arkray Factory USA is recalling specific lots of SPOTCHEM II test strips because they may display inaccurate glucose results for high values.
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 each of SPOTCHEM II Basic Panel-1 Reagent Test Strips and SPOTCHEM II Glucose Reagent Test Strips. The recall is due to a lowered reaction rate in the reagent pad for glucose. The affected lot number is PN5C26. The product quantity involved is 11 boxes, containing 25 foil-packaged test strips per box.
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 glucose levels may receive a reading that is lower than their actual value.
The affected products were distributed in the states of Florida, Illinois, Kentucky, Michigan, North Carolina, New York, Ohio, and Tennessee. Consumers and healthcare providers should stop using the affected test strips and contact Arkray Factory USA, Inc. for instructions on how to return the product.
The recalled product
- Product
- arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Urea Nitrogen, Glucose, Albumin, Creatinine. For the in vitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and…
- 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 PN5C26
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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