CLASS II Device recall · Reported 17 Oct 2012 · FDA Enforcement Report
IDS-iSYS N-Mid¿ Osteocalcin recalled by Immunodiagnostics Systems
Immunodiagnostics Systems is recalling IDS-iSYS N-Mid¿ Osteocalcin, distributed nationwide in the US. The recall was initiated on 10 Aug 2012 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-0042-2013
- FDA event ID
- 62968
- Recalling firm
- Immunodiagnostics Systems, Boldon Tyne & Wear, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Aug 2012
- FDA classified
- 10 Oct 2012
- Reported
- 17 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Test Kits & Diagnostics
Timeline
| 10 Aug 2012 | Recall initiated by company | |
| 10 Oct 2012 | Classified by FDA | +61 days |
| 17 Oct 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalcin Assay is intended for the quantitative determination of Osteocalcin in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to assist the clinician. Osteocalcin is an indicator of osteoblastic activity in human serum and plasma and is intended to be used as an aid in the prevention of osteoporosis.
Where it was distributed
Nationwide Distribution including NY, CA, ME and CT.
Questions about this recall
Is IDS-iSYS N-Mid¿ Osteocalcin recalled?
Yes. Immunodiagnostics Systems recalled IDS-iSYS N-Mid¿ Osteocalcin on 10 Aug 2012. The recall is Class II and its status is Terminated. Recall number Z-0042-2013.
Why was it recalled?
It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage.
Which lots are affected?
Lot 948 and 1145, EXP Aug 2012 and Jan 2013 respectively
Where was it sold?
Nationwide Distribution including NY, CA, ME and CT.
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.
More recalls from Immunodiagnostics Systems
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) recalled | Immunodiagnostics Systems | Foreign Material | Nationwide |
| Device | CLASS II | Ids-iSYS Intact Pinp recalled by Immunodiagnostics Systems | Immunodiagnostics Systems | Foreign Material | Nationwide |
| Device | CLASS II | IDS-iSYS N-Mid¿ Osteocalcin recalled by Immunodiagnostics Systems | Immunodiagnostics Systems | Foreign Material | Nationwide |
| Device | CLASS II | Ids-iSYS Intact Pinp Control Set recalled by Immunodiagnostics Systems | Immunodiagnostics Systems | Foreign Material | Nationwide |
| Device | CLASS II | IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set recalled | Immunodiagnostics Systems | Foreign Material | Nationwide |
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