Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2841-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 15, 2016

Date Posted: September 28, 2016

Recall Number: Z-2841-2016

Event ID: 73995

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.

Status: Terminated

Product Quantity: 525 units

Code Information:

SMN Number:10381403 Lot: 411 Expired: 2016-04

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated