FDA Medical Device Recalls (openFDA)
Diasorin Inc.: ETI-AB-AUK PLUS kits,REF P001931, DiaSorin S.p.A., 13040 Saluggia (VC), Italy, Distributed by: DiaSorin Inc., 1951 Northwestern Avenue, P.O. Box 285, Stillwater, MN 55082-0285 In vitro enzyme immunoassay (EIA) intended for use in the qualitative detection of antibodies to hepatitis B surface antigen (anti-HBs) in human serum or plasma.
- Recall number
- Z-1744-2011
- Recalling firm
- Diasorin Inc.
- Product
- ETI-AB-AUK PLUS kits,REF P001931, DiaSorin S.p.A., 13040 Saluggia (VC), Italy, Distributed by: DiaSorin Inc., 1951 Northwestern Avenue, P.O. Box 285, Stillwater, MN 55082-0285 In vitro enzyme immunoassay (EIA) intended for use in the qualitative detection of antibodies to hepatitis B surface antigen (anti-HBs) in human serum or plasma.
- Status
- Terminated
- Initiated
- 2010-08-19
- Posted
- 2011-03-22
- Terminated
- 2012-08-16
- Reason
- Through internal testing, DiaSorin has become aware that the kit lots identified (ETI-AB-AUK PLUS kits, catalog number P001931, lot numbers 0650270A and/or 0650270A/1) may not consistently exhibit stability to defined expiration dating, resulting in decreased binding and lower absorbance. Internal testing has confirmed that when defined assay validation criteria pass, analytical performance is co
- Root cause
- Other
- Action
- The firm, DiaSorin, sent a "Customer Notification Letter" dated 19 August, 2010 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to destroy all remaining inventory and complete and return the receipt of notification and destruction of product form, found in the bottom portion of the letter, via fax to: (651) 351-5669, ATTN: TECHNICAL SERVICES or mail to: ATTN: TECHNICAL SERVICES, 1951 Northwestern Ave., Stillwater, Minnesota 55082-0285. If you have any questions or concerns, please contact DiaSorin Inc., Technical Services at 1-800-328-1482 or 651-439-9710.
- Quantity
- 710
- Distribution
- Worldwide distribution: USA including states of: AL, AR, CA, CT, DE, DC, FL, GA, IL, IA, KY, LA, MD, MA, MI, MN, MO, NH, NJ, NM, NY, NC, ND, OH, OK OR, PA, TX, VT, VA, WA,and WI; and country of: SOUTH KOREA.
- Lot, serial or model codes
- lot numbers 0650270A and 0650270A/1.
- 510(k) numbers
- not on file
- PMA numbers
- ["P990042"]
- Product code
- LOM
- Firm FEI
- 2182595
- Firm city
- Stillwater
- Firm state
- MN
- Firm country
- not on file
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