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CoaguChek XS Prof (Professional) Meters- IVD professional… recallZ-0803-2021 · Roche Diagnostics Operations, Inc. · initiated Dec 2, 2020

Class II Terminated All recalls posted in January 2021

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Roche Diagnostics Operations, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results

FDA root cause category: Device Design

What the company is doing

Roche issued on 12/2/2020, UMDC letter notifications via UPS Ground (signature required upon receipt) to Healthcare Professionals, Distributors and Patients provides instructions to users for ensuring the meter is displaying INR results as follows: For the CoaguChek XS Pro system: UMDC for Healthcare Professionals (TP-01147); UMDC TP-01150 (Distributors), including an enclosed UMDC for Healthcare Professionals (TP-01147). For the CoaguChek XS PST system: UMDC for IDTFs (TP-01148) Including an enclosed UMDC for Patients (TP-01142);" UMDC for Clinics (TP-01149);o Including an enclosed UMDC for Patients (TP-01142). The UMDCs posted to the diagnostics.roche.com website. Distributors of CoaguChek Products are instructed as follows: " Read the enclosed Healthcare Professionals UMDC TP-01147 " Within 14 days from receipt of this UMDC distribute a copy of the enclosed Healthcare Professionals UMDC TP-01147 to all customers to whom you have shipped test strips to use with the Coaguchek XS Professional meter within the last 2 years. " If your organization is contractually authorized by Roche to ship test strips to use with the CoaguChek XS Professional meter to redistributors, then your organization must immediately send a copy of this Distributor UMDC TP-01150 and a copy of the enclosed Healthcare Professional UMDC TP-01147 to those re-distributor customers upon your receipt of this UMDC. Such redistributors should take each of the steps included in this Actions Required section of this Distributor UMDC with respect to their own healthcare professional customers. " Complete all sections of the enclosed fax back form (TP-01153); fax or email it according to the instructions on the form. " File this Urgent Medical Device Correction (UMDC) and the enclosed Healthcare Professional UMDC (TP-01147) for future " Healthcare Professionals (HCPs) considered direct government customers (i.e. VA, other government accounts) " If testing a patients INR at your f

Recall details

Recall number
Z-0803-2021
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 2, 2020
Posted by the FDA
Jan 7, 2021
Recalling firm
Roche Diagnostics Operations, Inc.
Quantity
212,093 units
Product code
GJS
FDA submissions
K060978
Distribution
US Nationwide

Product description

CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Catalog: 04837975001 Units could consist of any of the following strip configurations: 6 count, 24 count, 2x 24 count (i.e. 48 strips)* *CoaguChek XS 3x48 promo LTC HH Catalog: 06298176001 CoaguChek XS 6x24 promo LTC HH Catalog:08468699001 CoaguChek XS 4x48 promo Catalog: 08468745001 CoaguChek XS 6x48 promo Catalog: 08468753001

Code information (models, lots, serial numbers)

All serial numbers

Other devices under the same FDA submission

2 devices cleared under K060978 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 86951).

Sources and updates

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