# FDA recall Z-2117-2020

> **Abbott Gmbh & Co. KG** · Class II · device recall initiated 2020-04-24.

## Product

ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.

## Reason for recall

Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and  STAT High Sensitivity Troponin I assays (LN 3P25 and LN 2R98) may show interaction when  processed directly after the ARCHITECT iGentamicin (LN 1P31) assay and patient results might be impacted.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CT, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MT, ND, NE, NJ, NV, NY, OH, OK, PA, RI, SC, TN,TX, UT, VA, VT,  WA, WI, PR.    The countries of Algeria, Argentina, Australia, Austria, Bahrain, Barbados, Belarus, Belgium, Brazil, Brunei, Canada, Cayman Islands, Chile, China, Costa Rica, Croatia, Curacao, Czech Republic, Faroe Islands, France, Germany, Greece, Greenland, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Lithuania, Malaysia, Mauritius, Namibia, Netherlands, New Zealand, Norway, Oman, Palestinian Territory, Philippines, Poland, Portugal, Republic of Yemen, Saudi Arabia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tunisia, UAE, United Kingdom and Uruguay.

## Key facts

- **Recall number:** Z-2117-2020
- **Recalling firm:** Abbott Gmbh & Co. KG
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-04-24
- **Report date:** 2020-06-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wiesbaden, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2117-2020

## Citation

> AI Analytics. FDA recall Z-2117-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2117-2020. Source: US FDA. Licensed CC0.

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