HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220

FDA device recall Z-0515-2014 · posted 2013-12-16 · Terminated

Recall details

Recalling firm

Instrumentation Laboratory Co.

Reason for recall

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

Action taken

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.

Root cause

No Marketing Application

Status

Terminated

Product code

GGN

Quantity affected

6504 kits

Distribution

Nationwide Distribution

Date initiated

2013-11-15

Date posted

2013-12-16

Date terminated

2014-03-25

Location

Bedford, MA

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