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U.S. Department of Health and Human Services

Class 2 Device Recall Afinion 2, Afinion AS100 analyzer

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  Class 2 Device Recall Afinion 2, Afinion AS100 analyzer see related information
Date Initiated by Firm March 23, 2020
Create Date May 29, 2020
Recall Status1 Open3, Classified
Recall Number Z-2192-2020
Recall Event ID 85313
510(K)Number K182988  K180296  
Product Classification Hemoglobin A1c test system - Product Code PDJ
Product Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557, 1116597, 1116598, 1116663, 1116679, 1116680, 1116681, 1116682, 1116684, 1116770, 1116771, 1116772, 1116777, 1116778, 1116970, 1116971, 1116985, 1116986, IVD. The firm name on the label is Abbott Diagnostics Technologies AS, Oslo, Norway.

Power supply provided with Alere Afinion AS100 Analyzer, Catalog numbers 1115175, 1115390, 1116049, 1116050, 1116053, 1116054, 1116456, and 1116980. The firm name on the label is Alere Technologies AS, Oslo, Norway.
Code Information All serial numbers are affected.
Recalling Firm/
Manufacturer		 Abbott Diagnostics Technologies AS
Kjelsaasveien 161
Oslo Norway
For Additional Information Contact
866-2169505
Manufacturer Reason
for Recall		 The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the analyzers resulting in the power supply becoming non-functional.
FDA Determined
Cause 2		 Device Design
Action The recalling firm/manufacturer issued medical device correction letters dated 3/23/2020 on 3/23/2020 to their direct distributors requesting end user customer information. The recalling firm/manufacturer issued medical device correction letters to the end users dated 3/31/2020 via a third-party notification firm. The notification informed the end user of the issue and requested to be notified of the number of power supplies needed for replacement. The affected power supplies were to be discarded by the end user.
Quantity in Commerce 42,237 instruments
Distribution Distribution was made to NJ. There was no direct government/military distribution. Foreign distribution was made to Canada, Argentina, Australia, Bangladesh, Brazil, Cambodia, Chile, China, Colombia, Denmark, Finland, France, Georgia, Germany, Guatemala, Hong Kong, Iceland, India, Italy, Ivory Coast, Japan, Korea, Madagascar, Malaysia, Mexico, Mongolia, Myanmar, The Netherlands, Norway, Oman, Pakistan, Peru, Philippines, Poland, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Timur, Trinidad & Tobago, United Kingdom, and Zimbabwe.
Total Product Life Cycle TPLC Device Report
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = PDJ and Original Applicant = Alere Technologies AS
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