Recall Z-0516-2014 ยท GGN Plasma, Coagulation Control
Instrumentation Laboratory Co.
HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
| Date | Dec 16, 2013 (initiated Nov 15, 2013) |
| Status | Terminated |
| Reason | HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval |
| 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 C |
| Quantity | 84561 kits |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021022 | HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED) Instrumentation Laboratory CO, May 14, 2002 |
| K021023 | HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED) Instrumentation Laboratory CO, May 14, 2002 |
| K021024 | HEMOSIL HIGH ABNORMAL CONTROL ASSAYED Instrumentation Laboratory CO, May 16, 2002 |