Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 10, 2016
VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clinical Diagnostics, For in vitro diagnostic use only. For the quantitative measurement of total thyroxine (T4) 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 to aid in the differential diagnosis of thyroid disease.
Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic Products Total T4 Reagent Packs may show a negative bias prior to the open pack sto…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ortho-clinical Diagnostics recalled VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Uniqu… - a moderate-severity action.
VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Uniqu… was recalled by Ortho-clinical Diagnostics in August 10, 2016. Reason: Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic Products Tota…. Check the official notice for the remedy. Verify recall #Z-2302-2016 with the FDA Devices before acting.
The recall
Ortho-clinical Diagnostics issued this moderate-severity FDA Devices recall-Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic Products Tota….
- Moderate
- severity level
- Class II
- classification
- August 10, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2302-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2302-2016) was formally reported on August 10, 2016, with the manufacturer initiating the action on June 2, 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. Federal records list the affected scope as US: 12,015; Foreign: 55 Sales Units to Canada, 223 Sales Units shipped to Bermuda.
The documented reason for this recall is: Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic Products Total T4 Reagent Packs may show a negative bias prior to the open pack storage limit of <= 8 weeks that is located… Distribution data in the federal record shows the product reached: Worldwide Distribution - US (Nationwide including Puerto Rico) and foreign distribution to Canada and Bermuda. 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
US: 12,015; Foreign: 55 Sales Units to Canada, 223 Sales Units shipped to Bermuda
Related Recalls
6
3 from same agency
Product description
VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clinical Diagnostics, For in vitro diagnostic use only. For the quantitative measurement of total thyroxine (T4) 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 to aid in the differential diagnosis of thyroid disease.
Reason for recall
Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic Products Total T4 Reagent Packs may show a negative bias prior to the open pack storage limit of <= 8 weeks that is located in the Instructions for Use (IFU) for VITROS Immunodiagnostic Products Total T4 Reagent Pack.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2302-2016 |
| Date reported | August 10, 2016 |
| Date initiated | June 2, 2016 |
| Recalling firm | Ortho-clinical Diagnostics |
| Firm location | Bridgend |
| Affected scope | US: 12,015; Foreign: 55 Sales Units to Canada, 223 Sales Units shipped to Bermuda |
| Distribution | Worldwide Distribution - US (Nationwide including Puerto Rico) and foreign distribution to Canada and Bermuda |
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-2302-2016) 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 Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clinical Diagnostics, For in vitro diagnostic use only. For the quantitative measurement of total thyroxine (T4) 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 to aid in the differential diagnosis of thyroid disease.. Recalled by Ortho-clinical Diagnostics. Units affected: US: 12,015; Foreign: 55 Sales Units to Canada, 223 Sales Units shipped to Bermuda.
Why was this product recalled? ▼
Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic Products Total T4 Reagent Packs may show a negative bias prior to the open pack storage limit of <= 8 weeks that is located in the Instructions for Use (IFU) for VITROS Immunodiagnostic Products Total T4 Reagent Pack.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 10, 2016. Severity: Moderate. Recall number: Z-2302-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US (Nationwide including Puerto Rico) and foreign distribution to Canada and Bermuda.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2302-2016) 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 August 10, 2016. 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.