Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 17, 2012
IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) assay is intended for the quantitative determination of intact PINP in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser.
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 Un…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Immunodiagnostics Systems Ltd recalled IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plasti… - a moderate-severity action.
IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plasti… was recalled by Immunodiagnostics Systems Ltd in October 17, 2012. Reason: It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with …. Check the official notice for the remedy. Verify recall #Z-0044-2013 with the FDA Devices before acting.
The recall
Immunodiagnostics Systems Ltd issued this moderate-severity FDA Devices recall-It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with ….
- Moderate
- severity level
- 10 units
- affected scope
- Class II
- classification
- October 17, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0044-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0044-2013) was formally reported on October 17, 2012, with the manufacturer initiating the action on August 10, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Immunodiagnostics Systems Ltd is listed as the recalling firm, operating out of Boldon Tyne & Wear, N/A. Federal records list the affected scope as 10.
The documented reason for this recall is: 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 b… Distribution data in the federal record shows the product reached: Nationwide Distribution including NY, CA, ME and CT.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
10
Related Recalls
6
3 from same agency
Product description
IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) assay is intended for the quantitative determination of intact PINP in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0044-2013 |
| Date reported | October 17, 2012 |
| Date initiated | August 10, 2012 |
| Recalling firm | Immunodiagnostics Systems Ltd |
| Firm location | Boldon Tyne & Wear, N/A |
| Affected scope | 10 |
| Distribution | Nationwide Distribution including NY, CA, ME and CT. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0044-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) assay is intended for the quantitative determination of intact PINP in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser.. Recalled by Immunodiagnostics Systems Ltd. Units affected: 10.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on October 17, 2012. Severity: Moderate. Recall number: Z-0044-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution including NY, CA, ME and CT..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0044-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 17, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.