Abbott ARCHITECT Creatine Kinase recall
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.
Why was Abbott ARCHITECT Creatine Kinase recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.
- Recalling firm
- Abbott Laboratories, Inc
- Quantity
- 6,187 kits 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.
- Recall date
- April 10, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)