| Class 2 Device Recall Abbott ARCHITECT Creatine Kinase | |
Date Initiated by Firm | July 18, 2018 |
Create Date | March 30, 2019 |
Recall Status1 |
Terminated 3 on August 13, 2020 |
Recall Number | Z-1076-2019 |
Recall Event ID |
82116 |
510(K)Number | K983070 |
Product Classification |
Nad reduction/nadh oxidation, cpk or isoenzymes - Product Code CGS
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Product | Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341. |
Code Information |
Lot number 99633UN18, exp. 02JAN19, UDI (01)00380740101176(17)190102(10)99633UN18. |
Recalling Firm/ Manufacturer |
Abbott Laboratories, Inc 1921 Hurd Dr Irving TX 75038-4313
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For Additional Information Contact | Albert Chianello 877-422-2688 |
Manufacturer Reason for Recall | The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low. |
FDA Determined Cause 2 | Material/Component Contamination |
Action | Recall letters were issued via FedEx overnight priority mail on 7/18/2018. |
Quantity in Commerce | 30 kits |
Distribution | Distribution was made nationwide, including Puerto Rico. There was also government and military distribution.
Foreign distribution was made to Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bermuda, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mexico, Moldova, Morocco, Netherlands, Netherlands (Curacao), New Zealand, Norway, Oman, Pakistan, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, UAE, Uganda, United Kingdom, Uruguay, Vietnam, and Zimbabwe. |
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 = CGS
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