Z-2841-2016Class II

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

Name: Z-2841-2016 IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I)...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2016-04-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-04-15 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma on 2016-04-15. FDA classified it as Class II and gives the reason as "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)...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2841-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-15
Posted: 2016-09-16
Terminated: 2017-04-20
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.
Product code: CFL Radioimmunoassay, Human Growth Hormone
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.
FDA root cause: Unknown/Undetermined by firm
Action: 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.
Quantity in commerce: 525 units
Distribution: Domestic: IL, FL, NY, OH, LA, MO, MA; International: Canada, others will be inserted
Product codes and lots: SMN Number:10381403 Lot: 411 Expired: 2016-04

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2841-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2841-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-16

Product code CFL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)