On 12/19/2018, Save Rite Medical.com, LLC. initiated a nationwide recall of Roche CoaguChek test strips distributed directly to U.S. consumers by Save Rite Medical.com, LLC. This recall only includes CoaguChek test strips distributed directly to U.S. consumers by Save Rite Medical.com, LLC. via its website/phone calls/facsimal of All Catalog/REF Numbers that DO NOT END IN 160.
The products distributed by Save Rite Medical.com, LLC. have been found to inaccurately report high INR test results. Patients taking warfarin who receive inaccurate INR results above their target therapeutic range may be at risk for inappropriate therapeutic measures such as a warfarin dose reduction, interruption of warfarin use, or administration of vitamin K.
All Catalog/REF Numbers that DO NOT END IN 160
|
Product |
Catalog/REF Numbers |
Affected Lot Numbers |
|
CoaguChek XS Test Strips (All varieties sold by Save Rite Medical.com, LLC.) |
All Catalog/REF Numbers that do NOT end in 160 (see ex. image below) |
27216700 through 33449899 |
This recall is related to the recent Roche Diagnostics Recall, the manufacturer of CoaguChek meters and test strips. The CoaguChek test strips distributed by Save Rite Medical.com, LLC. include Catalog/REF numbers that were not included in the recent Roche recall because these items were not distributed by Roche Diagnostics in the United States.
Save Rite Medical.com, LLC. began distributing impacted products between 12/27/2017 through 12/15/2018 directly to consumers via courier service.
Save Rite Medical.com, LLC. voluntarily recalled product after becoming aware of consumer complaints.
Actions Required:
Immediately stop using all CoaguChek XS Test Strips listed above and purchased directly from Save Rite Medical.com, LLC.
Returns:
- Please send an E-Mail to marc@saveritemedical.com or call a customer service specialist at 866-923-1544 between the hours of 9:00 am - 5:00 pm, monday - thursday
- Return impacted strips directly to Save Rite Medical, 168 10th Street, Brooklyn, NY 11215-3821
Adverse reactions or quality problems experienced with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form fda.gov/MedWatch/getforms.htmor call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
