CoaguChek XS PT Test Strips Recalled for Abnormally High INR Results

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 order

Manufacturer

TERRIFIC CARE LLC

Category

Medical Device — Point-of-Care Testing

Hazard

• inaccurate-test-results

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.

Distribution

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