CLASS II Device recall · Reported 10 Apr 2019 · FDA Enforcement Report

Abbott Architect Creatine Kinase, IVD recalled by Abbott Laboratories

Abbott Laboratories is recalling Abbott Architect Creatine Kinase, IVD, distributed nationwide in the US. The recall was initiated on 18 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number 99633UN18, exp. 02JAN19, UDI (01)00380740101176(17)190102(10)99633UN18.

Quantity recalled30 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1076-2019
FDA event ID: 82116
Recalling firm: Abbott Laboratories, Irving, TX
Classification: Class II
Status: Terminated
Recall initiated: 18 Jul 2018
FDA classified: 30 Mar 2019
Reported: 10 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

18 Jul 2018	Recall initiated by company
30 Mar 2019	Classified by FDA	+255 days
10 Apr 2019	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.

Where it was distributed

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.

Nationwide Puerto Rico

Questions about this recall

Is Abbott Architect Creatine Kinase, IVD recalled?

Yes. Abbott Laboratories recalled Abbott Architect Creatine Kinase, IVD on 18 Jul 2018. The recall is Class II and its status is Terminated. Recall number Z-1076-2019.

Why was it 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.

Which lots are affected?

Lot number 99633UN18, exp. 02JAN19, UDI (01)00380740101176(17)190102(10)99633UN18.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Abbott Laboratories

All 153

Reported	Class	Recall	Company	Reason	Where
19 Nov 2025Device	CLASS II	Alinity hq Analyzer recalled by Abbott Laboratories	Abbott Laboratories	Device Malfunction	Nationwide
30 Apr 2025Device	CLASS II	Cell-dyn Ruby recalled by Abbott Laboratories	Abbott Laboratories	Device Malfunction	Nationwide
30 Apr 2025Device	CLASS II	Cell-dyn Ruby recalled by Abbott Laboratories	Abbott Laboratories	Device Malfunction	Nationwide
30 Apr 2025Device	CLASS II	Cell-dyn Ruby recalled by Abbott Laboratories	Abbott Laboratories	Device Malfunction	Nationwide
30 Apr 2025Device	CLASS II	Cell-dyn Ruby recalled by Abbott Laboratories	Abbott Laboratories	Device Malfunction	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide