CoaguChek XS PT Test Strips Recalled for Abnormally High INR Results
Terrific Care LLC is recalling CoaguChek XS PT Test Strips sold via MedEx Supply due to potential for abnormally high INR test results.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source metadata explicitly identifies the agency classification as Class I, which corresponds to a Critical severity score (5) per the rubric.
Plain-English summary
Terrific Care LLC is recalling CoaguChek XS PT Test Strips that were sold directly to customers through its website, telephone, or facsimile under the name MedEx Supply. The recall affects 793 boxes of the product, which includes all catalog and reference numbers that do not end in 160. These test strips are part of the CoaguChek XS System, intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.
The recall was initiated because of the potential for abnormally high INR test results. This issue may affect customers who purchased the products directly from Terrific Care LLC dba MedEx Supply. The source text does not specify a distribution scope beyond the direct sales channels mentioned, nor does it provide specific lot numbers other than noting all lot numbers sold by the firm.
Consumers who purchased these specific test strips from MedEx Supply should stop using them and contact the recalling firm for further instructions. The FDA has classified this as a Class I recall, indicating a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other…
- Manufacturer
- TERRIFIC CARE LLC
- Hazard
- Affected units
- 793
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)
- All Lot Numbers sold by Terrific Care LLC dba Medex Supply
Distribution
Distributed nationwide across the United States.
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