Abbott recalls ARCHITECT Creatine Kinase IVD with potential stability issues causing error codes and QC failures. Affected units include specific lot numbers and expiration dates.
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.
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Contact the company
📍Recalling firmAbbott Laboratories, Inc1921 Hurd Dr · Irving, TX 75038-4313
✎ GovInfoNow plain-language explainer
Abbott is recalling its ARCHITECT Creatine Kin:ase IVD test kit due to stability problems that might cause error messages or inaccurate quality control results. This could lead to incorrect test outcomes if the device is used without proper calibration. Read more at govinfonow.com/recall/70421-abbott-architect-creatine-kinase-recall-stability-error-risk.
“Abbott ARCHITECT Creatine Kinase Recall: Stability Error Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70421-abbott-architect-creatine-kinase-recall-stability-error-risk. Based on FDA recall #Z-1076-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1076-2019%22&limit=1).
The FDA announced on July 18, 2018, that Abbott Laboratories, Inc. voluntarily recalled its ARCHITECT Creatine Kinase IVD kits due to a stability issue. The hazard may cause error codes or out-of-range quality control results.
According to the FDA, 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.
Context
GovInfoNow's records show Abbott Laboratories, Inc. has 11 other recalls on record since Sept. 29, 2017. Other recent recalls of similar products include the Abbott Alinity s System Software Version 2.8.0 Recall (Feb. 3, 2022), the Abbott Alinity s System Recall (July 12, 2021), and the Abbott ARCHITECT C System Mixer Recall (May 1, 2019). Other recent recalls of similar products include the Siemens Dimension Creatinine Flex Reagent Cartridge Recall (March 18, 2026), the Abbott ID NOW Influenza A & B 2 Kit recall (Feb. 9, 2026), and the Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026).
How to tell if you have this one
Check for the lot number 99633UN18 with expiration date 02JAN19 on the product label. The unique device identifier (UDI) starts with (01)00380740101176(17)190102(10).
Brand
Abbott
Product
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
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 number
Product, codes & lots
Quantity
Z-1075-2019
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.; 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.
6,187 kits kits
Z-1076-2019
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.; Lot number 99633UN18, exp. 02JAN19, UDI (01)00380740101176(17)190102(10)99633UN18.
30 kits
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the lot number 99633UN18 and expiration date 02JAN19 on the device label.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1076-2019 (July 18, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1076-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.