Abbott Laboratories, Inc: Medical Device Recall in 2019 - (Recall #: Z-1075-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.

Product Classification:

Class II

Date Initiated: July 18, 2018

Date Posted: April 10, 2019

Recall Number: Z-1075-2019

Event ID: 82116

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.

Status: Terminated

Product Quantity: 6,187 kits kits

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated