FDA Medical Device Recalls (openFDA)
Abbott Gmbh & Co. KG: ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
- Recall number
- Z-1728-2020
- Recalling firm
- Abbott Gmbh & Co. KG
- Product
- ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
- Status
- Terminated
- Initiated
- 2020-03-09
- Posted
- not on file
- Terminated
- 2021-02-11
- Reason
- An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.
- Root cause
- Mixed-up of materials/components
- Action
- 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.
- Quantity
- 7,347 kits
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K113704"]
- PMA numbers
- not on file
- Product code
- LOL
- 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