Severity
Low
VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators -- Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK --- For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic Systems, and the VITROS 5600 Integrated System for the quantitative measurement of total 25-OH Vitamin D in human serum.
Reported: March 19, 2014 Initiated: January 15, 2014 #Z-1193-2014 1554 units domestically units
Ortho-Clinical Diagnostics issued this FDA Devices recall on March 19, 2014. Classified as Low severity (Class III). Approximately 1554 units domestically units are affected. The recall was issued because: Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators, …. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-1193-2014) was formally reported on March 19, 2014, with the manufacturer initiating the action on January 15, 2014. It is classified under Low severity (Class III), with a current status of Terminated. Ortho-Clinical Diagnostics is listed as the recalling firm, operating out of Rochester, NY. Federal records indicate 1554 units domestically units are affected.
The documented reason for this recall is: Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators, Lots 0091 through 0235, used with VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pac… Distribution data in the federal record shows the product reached: Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
1554 units domestically
Related Recalls
6
6 from same agency
Product Description
VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators -- Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK --- For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic Systems, and the VITROS 5600 Integrated System for the quantitative measurement of total 25-OH Vitamin D in human serum.
Reason for Recall
Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators, Lots 0091 through 0235, used with VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Packs, may generate negatively biased results. As a result, users must immediately discontinue using all current lots of VITROS 25-OH Vitamin D Total Calibrators and Reagent Packs.
Details
- Recalling Firm
- Ortho-Clinical Diagnostics
- Units Affected
- 1554 units domestically
- Distribution
- Nationwide
- Location
- Rochester, NY
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1193-2014 |
| Date reported | March 19, 2014 |
| Date initiated | January 15, 2014 |
| Recalling firm | Ortho-Clinical Diagnostics |
| Units affected | 1554 units domestically |
| Distribution | Nationwide |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators -- Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK --- For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic Systems, and the VITROS 5600 Integrated System for the quantitative measurement of total 25-OH Vitamin D in human serum.. Recalled by Ortho-Clinical Diagnostics. Units affected: 1554 units domestically.
Why was this product recalled? ▼
Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators, Lots 0091 through 0235, used with VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Packs, may generate negatively biased results. As a result, users must immediately discontinue using all current lots of VITROS 25-OH Vitamin D Total Calibrators and Reagent Packs.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 19, 2014. Severity: Low. Recall number: Z-1193-2014.
Where was the recalled product distributed? ▼
Distribution: Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1193-2014) 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
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- 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)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product 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.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).