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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott ARCHITECT Creatine Kinase

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 Class 2 Device Recall Abbott ARCHITECT Creatine Kinasesee related information
Date Initiated by FirmJuly 18, 2018
Create DateMarch 30, 2019
Recall Status1 Terminated 3 on August 13, 2020
Recall NumberZ-1075-2019
Recall Event ID 82116
510(K)NumberK983070 
Product Classification Nad reduction/nadh oxidation, cpk or isoenzymes - Product Code CGS
ProductAbbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.
Code Information Lot number 87697UN18, exp. 22OCT18; UDI (01)00380740012878 (17)181022(10)87697UN18;  Lot number 99632UN18, exp. 12NOV18, UDI (01)00380740012878 (17)181112(10)99632UN18; and  Lot 24358UN18, exp. 05DEC18, UDI (01)00380740012878 (17)181205(10)24358UN18.
Recalling Firm/
Manufacturer		 Abbott Laboratories, Inc
1921 Hurd Dr
Irving TX 75038-4313
For Additional Information ContactAlbert 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
ActionRecall letters were issued via FedEx overnight priority mail on 7/18/2018.
Quantity in Commerce6,187 kits kits
DistributionDistribution 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 CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = CGS
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