# FDA recall Z-2192-2020

> **Abbott Diagnostics Technologies AS** · Class II · device recall initiated 2020-03-23.

## Product

Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557, 1116597, 1116598, 1116663, 1116679, 1116680, 1116681, 1116682, 1116684, 1116770, 1116771, 1116772, 1116777, 1116778, 1116970, 1116971, 1116985, 1116986, IVD.  The firm name on the label is Abbott Diagnostics Technologies AS, Oslo, Norway.    Power supply provided with Alere Afinion AS100 Analyzer, Catalog numbers 1115175, 1115390, 1116049, 1116050, 1116053, 1116054, 1116456, and 1116980.  The firm name on the label is Alere Technologies AS, Oslo, Norway.

## Reason for recall

The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the analyzers resulting in the power supply becoming non-functional.

## Distribution

Distribution was made to NJ.  There was no direct government/military distribution.    Foreign distribution was made to Canada, Argentina, Australia, Bangladesh, Brazil, Cambodia, Chile, China, Colombia, Denmark, Finland, France, Georgia, Germany, Guatemala, Hong Kong, Iceland, India, Italy, Ivory Coast, Japan, Korea, Madagascar, Malaysia, Mexico, Mongolia, Myanmar, The Netherlands, Norway, Oman, Pakistan, Peru, Philippines, Poland, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Timur, Trinidad & Tobago, United Kingdom, and Zimbabwe.

## Key facts

- **Recall number:** Z-2192-2020
- **Recalling firm:** Abbott Diagnostics Technologies AS
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-03-23
- **Report date:** 2020-06-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Oslo, N/A, Norway

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2192-2020

## Citation

> AI Analytics. FDA recall Z-2192-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-2192-2020. Source: US FDA. Licensed CC0.

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