# FDA recall Z-1076-2019

> **Abbott Laboratories, Inc** · Class II · device recall initiated 2018-07-18.

## Product

Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.

## 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.

## 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,

## Key facts

- **Recall number:** Z-1076-2019
- **Recalling firm:** Abbott Laboratories, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-18
- **Report date:** 2019-04-10
- **Termination date:** 2020-08-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irving, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1076-2019

## Citation

> AI Analytics. FDA recall Z-1076-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1076-2019. Source: US FDA. Licensed CC0.

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