Instrumentation Laboratory Co.: Medical Device Recall in 2013 - (Recall #: Z-0516-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320

Product Classification:

Class II

Date Initiated: November 15, 2013

Date Posted: December 25, 2013

Recall Number: Z-0516-2014

Event ID: 66894

Reason for Recall:

HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval

Status: Terminated

Product Quantity: 84561 kits

Code Information:

All lots

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated