The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0360-2019·Announced 2018-11-14

Roche CoaguChek XS Prothrombin Time Test Strips Recalled for High INR Results

Roche Diagnostics is recalling CoaguChek XS Prothrombin Time test strips nationwide because they may produce abnormally high INR 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 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: "Abnormally high INR test results with the affected CoaguChek test strips"

Plain-English summary

Roche Diagnostics Corporation is recalling specific lots of CoaguChek XS System Prothrombin Time (PT) test strips. The affected products include the CoaguChek XS PT Test 2X24 Strips, 6 Strips, and 24 Tests, distributed nationwide. The recall involves approximately 1,163,952 boxes of the test strips.

The recall was initiated because the affected test strips may produce abnormally high International Normalized Ratio (INR) test results. This potential for inaccurate readings could impact the monitoring of patients using the device.

Consumers and healthcare providers should stop using the affected test strips and contact Roche Diagnostics for further instructions or a replacement. The specific lot numbers and catalog numbers affected are detailed in the official recall notice.

The recalled product

Product
CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160; CoaguChek XS PT Test 24 Tests, Catalog Number: 07797826160;
Manufacturer
Roche Diagnostics Corporation
Category
Medical Device — Point-of-Care Testing
Hazard
Affected units
1,163,952

Distribution

Distributed nationwide across the United States.

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