ARCHITECT recallZ-1728-2020 · Abbott Gmbh & Co. KG · initiated Mar 9, 2020
Terminated
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
An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.
FDA root cause category: Mixed-up of materials/components
What the company is doing
Abbott GmbH notified customers on 03/09/2020 via "Product Recall Urgent Immediate Action Required" letter. The recall letter identified the affected products and requested the customers to Immediately discontinue use of, and destroy, any remaining inventory of these ARCHITECT HAVABG reagent lots.
Recall details
- Recall number
- Z-1728-2020
- Status
- Terminated
- Initiated by the company
- Mar 9, 2020
- Recalling firm
- Abbott Gmbh & Co. KG
- Quantity
- 7,347 kits
- Product code
- LOL
- FDA submissions
- K113704
- Distribution
- US nationwide including the states of AL, AR, AZ, CA, CO, CT DE, FL, GA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM NV, NY, OH, OK, OR, PA, RH, SC, TN, TZ, UT, VA, WA, WI, WV AND PR.
Product description
ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
Code information (models, lots, serial numbers)
List Number 6L27 25. Lot No: 03429BE00, 06172BE00, 08073BE00, 10353BE00. UDI: (01)00380740011185 (17)200320(10)03429BE00, (01)00380740011185 (17)200604(10)06172BE00, (01)00380740011185 (17)200819(10)08073BE00, (01)00380740011185 (17)201023(10)10353BE00.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ARCHITECT 6L27-25Abbott GmbH · KIT, SEROLOGICAL, NEGATIVE CONTROL1 recall111 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K113704 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ARCHITECT 6L27-01Abbott GmbH · CALIBRATOR, PRIMARY1 report
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 16, 2026. Text above is shown as published by the FDA.
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