Recall Z-0515-2014— Instrumentation Laboratory Co.
Class II · Terminated
Class II FDA medical device recall by Instrumentation Laboratory Co., initiated 2013-11-15, terminated 2014-03-25. It names 3 FDA 510(k) clearances: K021024, K021022, K021023. Product: HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220. Reason: HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval.
- Recalling firm
- Instrumentation Laboratory Co.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-15
- Terminated
- 2014-03-25
- Firm location
- Bedford, MA, United States
510(k) clearances named in this recall
3 on FDA's record- K021024 — HEMOSIL HIGH ABNORMAL CONTROL ASSAYED
- K021022 — HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)
- K021023 — HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED)
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
Reason for recall
HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
Data sourced from openFDA. This site is unofficial and independent of the FDA.