Nidek ARK-1s Auto Ref/Keratometer Recalled for Measurement Discrepancy
Nidek Inc. is recalling 63 ARK-1s Auto Ref/Keratometers because there may be a difference between subjective and objective dioptric measurements.
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: The recall is classified as FDA Class II. The hazard involves a potential measurement discrepancy in a diagnostic device, which is a functional defect rather than a direct physical injury risk, fitting the criteria for a moderate severity recall.
Plain-English summary
Nidek Inc. is recalling 63 units of the AUTO REF/KERATOMETER ARK-1s. The recall was initiated because there is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on the device.
The affected units were distributed domestically to Alaska, Alabama, Arkansas, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Missouri, Montana, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, and West Virginia. The recall covers specific serial numbers ranging from 620337 to 620489.
Healthcare providers and consumers should stop using the affected devices and contact Nidek Inc. for further instructions.
The recalled product
- Product
- AUTO REF/KERATOMETER ARK-1s
- Manufacturer
- Nidek Inc.
- Hazard
- Affected units
- 63
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 (20)
- Model No. ARK-1s
- Serial No. 620337
- 620340
- 620341
- 620343
- 620345
- 620349
- 620350
- 620355
- 620356
- 620359
- 620363
- 620370
- 620371
- 620374
- 620376
- 620377
- 620380
- 620381
- 620384
Distribution
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