Medica EasyCAL HbA1c Calibrator Recalled for Potential Result Deviations
Medica Corporation is recalling EasyCAL HbA1c Calibrator kits because patient results may deviate up to 20 percent.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where patient results may deviate significantly (up to 20%), posing a risk of incorrect clinical decisions, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medica Corporation is recalling the EasyCAL HbA1c Calibrator, Reference 10658. The product is a kit packaged in a paper box containing four vials of 0.25ml calibrant and an insert sheet.
The recall was initiated because patient results determined using this specific calibrator lot might deviate up to 20 percent. The source notes that controls might not indicate false values.
The affected lot is number 16292. Distribution included the United States (Michigan, Florida, California, Texas), India, Russia, Puerto Rico, and the Northern Mariana Islands/Palau.
The recalled product
- Product
- EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet.
- Manufacturer
- Medica Corporation
- Hazard
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)
- Medica s Lot # 16292
Distribution
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