—#145849

Product

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

FDA product code: CFL — Radioimmunoassay, Human Growth Hormone
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: SMN Number:10381403 Lot: 411 Expired: 2016-04

Why it was recalled

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.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

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

Timeline

Recall initiated: 2016-04-15
Posted by FDA: 2016-09-16
Terminated: 2017-04-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #145849. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.