ETI-AB-AUK PLUS kits,REF P001931, DiaSorin S.p.A., 13040 Saluggia (VC), Italy, Distributed by: DiaSorin Inc., 1951 North

FDA device recall Z-1744-2011 · posted 2011-03-22 · Terminated

Recall details

Recalling firm

Diasorin Inc.

Reason for recall

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

Action taken

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.

Root cause

Other

Status

Terminated

Product code

LOM

Quantity affected

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

Date initiated

2010-08-19

Date posted

2011-03-22

Date terminated

2012-08-16

Location

Stillwater, MN