Z-1075-2019Class II

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

Name: Z-1075-2019 Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21
Creator: Abbott Laboratories, Inc
Published: 2018-07-18
License: https://open.fda.gov/license/

Abbott Medical / initiated 2018-07-18 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories, Inc began a recall of Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21 on 2018-07-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1075-2019
Classification: Class II
Status: Terminated
Initiated: 2018-07-18
Posted: 2019-03-30
Terminated: 2020-08-13
Recalling firm: Abbott Medical
Product: Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.
Product code: CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Recall letters were issued via FedEx overnight priority mail on 7/18/2018.
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1075-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1075-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-10	2019-03-30
Z-1076-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-10	2019-03-30

Product code CGS

K983070Class IICkAbbott Laboratories / cleared 1999-02-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)