IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum o

FDA device recall Z-2841-2016 · posted 2016-09-16 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

24 minutes of incubation is required prior to processing patient samples and for the pretreatment solution to reach full equilibration when using pretreatment solution when using the pretreatment solution (LGFA) contained in the kit.

Action taken

On April 15, 2016, Siemens Healthcare Diagnostics Inc. distributed Urgent Medical Device Correction notices to their domestic customers and Urgent Field Safety Notices to their internationally customers via courier service. Customers are advised to take the following four actions: 1) To continue using IGF-I kit lot 411 and the associated pretreatment solution lot 055 to report patient results, ensure the IGF-I pretreatment solution is allowed to incubate with the patient sample for a minimum of 24 minutes prior to processing on the IMMULITE/IMMULITE 1000 systems. 2) Complete and return the Effectiveness Check Form attached to the letter within 30 days. 3) Please review the letter with your Medical Director. 4) If you have received any complaints of illness or adverse events associated with the product, immediately contact your local Siemens Customer Care Center or your local Siemens technical support representative. If customers have further distributed the product, please retain the letter with your laboratory records, and forward to those who may have received this product.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

CFL

Quantity affected

525 units

Distribution

Domestic: IL, FL, NY, OH, LA, MO, MA; International: Canada, others will be inserted

Date initiated

2016-04-15

Date posted

2016-09-16

Date terminated

2017-04-20

Location

Tarrytown, NY