Z-0516-2014Class II

HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320

Name: Z-0516-2014 HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
Creator: Instrumentation Laboratory Co.
Published: 2013-11-15
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2013-11-15 / Terminated

FDA source

Instrumentation Laboratory Co. began a recall of HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320 on 2013-11-15. FDA classified it as Class II and gives the reason as "HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0516-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-15
Posted: 2013-12-16
Terminated: 2014-03-25
Recalling firm: Instrumentation Laboratory Co.
Product: HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
Product code: GGN Plasma, Coagulation Control
Reason for recall: HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
FDA root cause: No Marketing Application
Action: Instrumentation Laboratory issued Important Correction Notice via USPS to US customers dated November 2013 advising users in the US that unassayed controls are not acceptable for use in their unassayed (non-value assigned) format. IL will no longer sell or distribute controls without assayed values for the US market as of November 15, 2013, and are converting US customers to an assayed control format. Additional contact with customers via phone calls and a reminder email. An enclosed response tracking form provided to be returned. For technical questions, contact the IL Technical Support Center at 1-800-678-0710, Option # 6 (ACL Coagulation Products). For replacement product if value assignments are not available for your product lot, please contact your IL Customer Service Representative at 1-800-955-9525, Option # 6. For questions regarding this recall call 781-861-4467.
Quantity in commerce: 84561 kits
Distribution: Nationwide Distribution
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0516-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0514-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-16
Z-0515-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-16
Z-0516-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-16

Product code GGN

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)