FDA Medical Device Recalls (openFDA)
Abbott Gmbh & Co. KG: 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.
- Recall number
- Z-2117-2020
- Recalling firm
- Abbott Gmbh & Co. KG
- 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.
- Status
- Open, Classified
- Initiated
- 2020-04-24
- Posted
- 2020-05-12
- Terminated
- not on file
- Reason
- 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.
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K102699"]
- PMA numbers
- not on file
- Product code
- LCD
- Firm FEI
- 3002809144
- Firm city
- Wiesbaden
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28