Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 4, 2017
VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892 - Reagent Pack, 2) UPN 10758750006250 / Product Code 6802893 - Calibrators For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Intact PTH is indicated to aid in the differential diagnosis of hyperpara
The device defect is a positive bias of up to 20% relative to the currently marketed Roche device. In addition, the firm states that during the investigation they discovered that …
Ortho-clinical Diagnostics recalled VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product… — a moderate-severity action.
VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product… was recalled by Ortho-clinical Diagnostics in January 4, 2017. Reason: The device defect is a positive bias of up to 20% relative to the currently marketed Roche device. In additio…. Check the official notice for the remedy. Verify recall #Z-0903-2017 with the FDA Devices before acting.
The recall
Ortho-clinical Diagnostics issued this moderate-severity FDA Devices recall — The device defect is a positive bias of up to 20% relative to the currently marketed Roche device. In additio….
- Moderate
- severity level
- Class II
- classification
- January 4, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0903-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0903-2017) was formally reported on January 4, 2017, with the manufacturer initiating the action on October 5, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Ortho-clinical Diagnostics is listed as the recalling firm, operating out of Bridgend, N/A. Federal records list the affected scope as 7,027 Total units.
The documented reason for this recall is: The device defect is a positive bias of up to 20% relative to the currently marketed Roche device. In addition, the firm states that during the investigation they discovered that the cleared reference interval (RI) was … Distribution data in the federal record shows the product reached: Worldwide Distribution - Nationwide Distribution : and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, G…. 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, 6 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 — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 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
7,027 Total units
Related Recalls
6
6 from same agency
Product description
VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892 - Reagent Pack, 2) UPN 10758750006250 / Product Code 6802893 - Calibrators For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Intact PTH is indicated to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy and can be used intraoperatively
Reason for recall
The device defect is a positive bias of up to 20% relative to the currently marketed Roche device. In addition, the firm states that during the investigation they discovered that the cleared reference interval (RI) was not set optimally at product launch in 2010 and that the upper limit in the IFU of 53.5pg/mL is too low and should be closer to 80 pg/mL. They are in the process of submitting the data to support the revised RI in a new 510K submission and will be changing the IFU once the 510K is cleared.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0903-2017 |
| Date reported | January 4, 2017 |
| Date initiated | October 5, 2016 |
| Recalling firm | Ortho-clinical Diagnostics |
| Firm location | Bridgend, N/A |
| Affected scope | 7,027 Total units |
| Distribution | Worldwide Distribution - Nationwide Distribution : and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain… |
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-0903-2017) 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? ▼
VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892 - Reagent Pack, 2) UPN 10758750006250 / Product Code 6802893 - Calibrators For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Intact PTH is indicated to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy and can be used intraoperatively. Recalled by Ortho-clinical Diagnostics. Units affected: 7,027 Total units.
Why was this product recalled? ▼
The device defect is a positive bias of up to 20% relative to the currently marketed Roche device. In addition, the firm states that during the investigation they discovered that the cleared reference interval (RI) was not set optimally at product launch in 2010 and that the upper limit in the IFU of 53.5pg/mL is too low and should be closer to 80 pg/mL. They are in the process of submitting the data to support the revised RI in a new 510K submission and will be changing the IFU once the 510K is cleared.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 4, 2017. Severity: Moderate. Recall number: Z-0903-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - Nationwide Distribution : and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0903-2017) 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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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported January 4, 2017.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. 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 June 2026.