Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported July 13, 2016
VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30), REF 680 2001, and Assay Data Disk (ADD), REF/Product Code 6801876 (Unique Device No. 10758750001576), Data Release Versions (DRVs) 5870 through 5883 inclusive; IVD --- Ortho-Clinical Diagnostics For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 29 is used to calibrate the VITROS 5,1 FS Chemistry System, the VIT
Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC Reagent GEN 30 product. Ortho's investigation confirmed that incorrect…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ortho-Clinical Diagnostics recalled VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjuncti… - a low-severity action.
VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjuncti… was recalled by Ortho-Clinical Diagnostics in July 13, 2016. Reason: Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC R…. Check the official notice for the remedy. Verify recall #Z-2119-2016 with the FDA Devices before acting.
The recall
Ortho-Clinical Diagnostics issued this low-severity FDA Devices recall-Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC R….
- Low
- severity level
- Class III
- classification
- July 13, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2119-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2119-2016) was formally reported on July 13, 2016, with the manufacturer initiating the action on May 24, 2016. 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 list the affected scope as US: 1517; Foreign: 842.
The documented reason for this recall is: Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC Reagent GEN 30 product. Ortho's investigation confirmed that incorrect calibration mathematics were assigned t… Distribution data in the federal record shows the product reached: Worldwide Distribution - US (Nationwide, Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, Poland, a…. 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 low 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: 1517; Foreign: 842
Related Recalls
6
3 from same agency
Product description
VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30), REF 680 2001, and Assay Data Disk (ADD), REF/Product Code 6801876 (Unique Device No. 10758750001576), Data Release Versions (DRVs) 5870 through 5883 inclusive; IVD --- Ortho-Clinical Diagnostics For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 29 is used to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent.
Reason for recall
Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC Reagent GEN 30 product. Ortho's investigation confirmed that incorrect calibration mathematics were assigned to the Calibrator Kit 29 Lots 2915 and 2995 supporting dTIBC Reagent GEN 30 product.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-2119-2016 |
| Date reported | July 13, 2016 |
| Date initiated | May 24, 2016 |
| Recalling firm | Ortho-Clinical Diagnostics |
| Firm location | Rochester, NY |
| Affected scope | US: 1517; Foreign: 842 |
| Distribution | Worldwide Distribution - US (Nationwide, Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, Poland, and Venezuela. |
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-2119-2016) 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 Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30), REF 680 2001, and Assay Data Disk (ADD), REF/Product Code 6801876 (Unique Device No. 10758750001576), Data Release Versions (DRVs) 5870 through 5883 inclusive; IVD --- Ortho-Clinical Diagnostics For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 29 is used to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent.. Recalled by Ortho-Clinical Diagnostics. Units affected: US: 1517; Foreign: 842.
Why was this product recalled? ▼
Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC Reagent GEN 30 product. Ortho's investigation confirmed that incorrect calibration mathematics were assigned to the Calibrator Kit 29 Lots 2915 and 2995 supporting dTIBC Reagent GEN 30 product.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 13, 2016. Severity: Low. Recall number: Z-2119-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US (Nationwide, Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, Poland, and Venezuela..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2119-2016) 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 July 13, 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.