ARCHITECT iGentamicin Reagent Kit - Product Usage: The… recallZ-2117-2020 · Abbott Gmbh & Co. KG · initiated Apr 24, 2020
Class II Open, Classified All recalls posted in May 2020
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Gmbh & Co. KG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2117-2020
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Apr 24, 2020
- Posted by the FDA
- May 12, 2020
- Recalling firm
- Abbott Gmbh & Co. KG
- Quantity
- 6087 Reagent Kits
- Product code
- LCD
- FDA submissions
- K102699
- 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 description
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.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
1 device cleared under K102699 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ARCHITECT 1P31-25Abbott GmbH · ENZYME IMMUNOASSAY, GENTAMICIN2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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