ARCHITECT iGentamicin Reagent Kit — Class II medical device recall Z-2117-2020

Ongoing recall by Abbott Gmbh & Co. KG, reported 2020-06-03, distributed nationwide. Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High Sensitivity T

Recall number	`Z-2117-2020`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Abbott Gmbh & Co. KG, Wiesbaden, N/A, Germany
Recall initiated	2020-04-24
Classified	2020-05-26
Reported by FDA	2020-06-03
Distributed	Nationwide (US)
Countries outside the US	AE, AR, AT, AU, BB, BE, BH, BR, CA, CH, CL, CN, CR, CW, CZ, DE, DZ, ES, FR, GB, GR, HK, HR, HU, IE, IL, IT, JO, JP, KE, KR, KY, LB, LK, LT, LV, MY, NL, NO, NZ, OM, PH, PL, PT, SA, SE, SI, SK, TN, TW, UY, ZA
Quantity	6,087 reagent
Reason classes	potency
Lot numbers	`04281BE00`, `08510BE00`, `11221BE00`, `2020-AUG-08`, `2020-MAY-21`, `2020-NOV-18`
Model numbers	`1P31-25`

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2117-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.