Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported June 3, 2020
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.
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 pr…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Abbott Gmbh & Co. Kg recalled ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in … - a moderate-severity action.
ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in … was recalled by Abbott Gmbh & Co. Kg in June 3, 2020. Reason: Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High Sensitivity…. Check the official notice for the remedy. Verify recall #Z-2117-2020 with the FDA Devices before acting.
The recall
Abbott Gmbh & Co. Kg issued this moderate-severity FDA Devices recall-Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High Sensitivity….
- Moderate
- severity level
- Class II
- classification
- June 3, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2117-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2117-2020) was formally reported on June 3, 2020, with the manufacturer initiating the action on April 24, 2020. It is classified under Moderate severity (Class II), with a current status of Ongoing. Abbott Gmbh & Co. Kg is listed as the recalling firm, operating out of Wiesbaden, N/A. Federal records list the affected scope as 6087 Reagent Kits.
The documented reason for this recall is: 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 iGe… Distribution data in the federal record shows the product reached: 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, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Where this recall sits in the database
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
6087 Reagent Kits
Related Recalls
6
0 from same agency
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2117-2020 |
| Date reported | June 3, 2020 |
| Date initiated | April 24, 2020 |
| Recalling firm | Abbott Gmbh & Co. Kg |
| Firm location | Wiesbaden, N/A |
| Affected scope | 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 c… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2117-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Abbott Gmbh & Co. Kg. Units affected: 6087 Reagent Kits.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 3, 2020. Severity: Moderate. Recall number: Z-2117-2020.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2117-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported June 3, 2020.
- Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.