CLASS II Device recall · Reported 25 Dec 2013 · FDA Enforcement Report
HemosIL Low Abnormal Control 2 Unassayed recalled
Instrumentation Laboratory is recalling HemosIL Low Abnormal Control 2 Unassayed, distributed nationwide in the US. The recall was initiated on 15 Nov 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0515-2014
- FDA event ID
- 66894
- Recalling firm
- Instrumentation Laboratory, Bedford, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Nov 2013
- FDA classified
- 16 Dec 2013
- Reported
- 25 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 15 Nov 2013 | Recall initiated by company | |
| 16 Dec 2013 | Classified by FDA | +31 days |
| 25 Dec 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
Where it was distributed
Nationwide Distribution
Questions about this recall
Is HemosIL Low Abnormal Control 2 Unassayed recalled?
Yes. Instrumentation Laboratory recalled HemosIL Low Abnormal Control 2 Unassayed on 15 Nov 2013. The recall is Class II and its status is Terminated. Recall number Z-0515-2014.
Why was it recalled?
HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
Which lots are affected?
All lots
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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