| Class 2 Device Recall AccuChek Aviva Plus Test Strip | |
Date Initiated by Firm | May 07, 2018 |
Date Posted | May 09, 2018 |
Recall Status1 |
Terminated 3 on January 16, 2020 |
Recall Number | Z-2185-2018 |
Recall Event ID |
80018 |
510(K)Number | K131029 |
Product Classification |
Glucose dehydrogenase, glucose - Product Code LFR
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Product | Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001
Product Usage:
The Accu-Chek Aviva Plus test strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. |
Code Information |
Lots 496947, 497291, 497296, 497325 |
Recalling Firm/ Manufacturer |
Roche Diabetes Care, Inc. 9115 Hague Rd Indianapolis IN 46256-1025
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Manufacturer Reason for Recall | The recalling firm identified four US lots of test strips out of specification. Affected strips show increased potential for strip errors prior to applying blood, strips not detected once inserted, or biased results, which may not be detectable. In the case of a biased result, incorrect action could be taken by the user in response to the displayed blood glucose result.
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FDA Determined Cause 2 | Equipment maintenance |
Action | "On May 7, 2018, the firm sent Urgent Medical Device Correction letters to affected Retailers, Suppliers, and Patients. Patients were instructed to check their test strip supply lot numbers against the recalled lots. Any test strips from the affected lots must be discarded.
To get replacement test strips, patients should use one of the following options:
o For fastest replacement of your product, please submit your request at
https://notices.accu-chek.com
o Email Accu-Chek Customer Care at accu-chek.care@roche.com and include
the following information: your name, full mailing address, phone number,
test strip lot number and number of affected test strip vials.
o For questions regarding this recall, contact Accu-Chek Customer Care
line at 1-800-358-4866 Monday through Friday between the hours of 8:00 am
and 8:00 pm Eastern Standard Time.
Suppliers were instructed to discontinue distribution and dispose of any remaining stock of the affected lots immediately. Suppliers were also asked to forward recall notifications to their customers, including both supplier- and consumer-level customers. Suppliers were asked to complete a faxback form indicating the total number of vials disposed of by the supplier and supplier customers. If you are a supplier and have questions about the information in this notification, please contact your Roche Account Manager.
Retailers were instructed to discontinue sale or distribution and dispose of remaining affected lots in stock. Retailers were also asked to provide recall notification to their consumer customers. Retailers may note the quantity disposed and contact their Suppliers to arrange for credit. For questions please contact your wholesaler or the Accu-Chek Customer Care line at 1-800-358-4866 Monday through Friday between the hours of 8:00 am and 8:00 pm Eastern Standard Time.
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Quantity in Commerce | 295, 248 |
Distribution | Worldwide Distribution - US Nationwide distribution. Foreign distribution to Argentina
Armenia
Australia
Austria
Azerbaijan
Bahamas
Bahrain
Barbados
Belgium
Brazil
Bulgaria
Canada
Chile
China
Colombia
Costa Rica
Denmark
Dominican Republic
El Salvador
Finland
Georgia
Germany
Ghana
Greece
Guatemala
Honduras
Hong Kong (SAR China)
Hungary
India
Indonesia
Israel
Italy
Jamaica
Japan
Jordan
Ireland
Kenya Korea Kuwait Lebanon Lithuania Luxembourg Malaysia Malta Mexico Myanmar Netherlands New Zealand Norway Oman Pakistan Philippines Poland Russian Federation New Zealand Saudi Arabia Serbia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan (Republic of China), Thailand, United Arab Emirates, United Kingdom, Vietnam, Portugal" |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = LFR
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