Z-2117-2020Class II

ARCHITECT iGentamicin Reagent Kit -

Name: Z-2117-2020 ARCHITECT iGentamicin Reagent Kit -
Creator: Abbott Gmbh & Co. KG
Published: 2020-04-24
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-04-24 / Open, Classified

FDA source

Abbott Gmbh & Co. KG began a recall of ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring... on 2020-04-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2117-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-04-24
Posted: 2020-05-12
Recalling firm: Abbott Medical
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.
Product code: LCD Enzyme Immunoassay, Gentamicin
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.
FDA root cause: Under Investigation by firm
Action: On April 24, 2020, Abbott issued a Product Correction letter to all customers who received shipments of the three impacted lots of ARCHITECT iGenatamicin Reagent kits. U.S. customers were sent the letter via FedEx priority overnight express. In the U.S., the customers will be requested to return to Abbott a Customer Reply Form acknowledging the receipt or a request for assistance.
Quantity in commerce: 6087 Reagent Kits
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.
Product codes and lots: MODEL: 1P31-25 LOT NUMBERS: 04281BE00, 08510BE00 and 11221BE00 Shelf life per LOT: 04281BE00;2020-MAY-21 08510BE00; 2020-AUG-08 11221BE00;2020-NOV-18

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2117-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2117-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-03	2020-05-26

Product code LCD

K102699Class IIArchitect Igentamicin Reagents; Architect Igentamicin CalibratorsAbbott Laboratories / cleared 2011-04-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)