Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 31, 2021
VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems Product Code: 1204668 Impacted Products: A. VITROS Chemistry Products TIBC Kit Product No: 7541 (UDI 8750005178) All current and new lots B. VITROS Chemistry Products Fe Slides Product No: 1924547 90 Slides (UDI 10758750000289) Product No: 1515808 300 slides (UDI 10758750009244) Produc
Potential total iron-binding capacity (TIBC) results. The VITROS TIBC performance shift will start with the newest Generation (GEN) of VITROS Fe Slides (GEN 26), the potential sh…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ortho-Clinical Diagnostics, Inc. recalled VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to ca… - a moderate-severity action.
VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to ca… was recalled by Ortho-Clinical Diagnostics, Inc. in March 31, 2021. Reason: Potential total iron-binding capacity (TIBC) results. The VITROS TIBC performance shift will start with the …. Check the official notice for the remedy. Verify recall #Z-1295-2021 with the FDA Devices before acting.
The recall
Ortho-Clinical Diagnostics, Inc. issued this moderate-severity FDA Devices recall-Potential total iron-binding capacity (TIBC) results. The VITROS TIBC performance shift will start with the ….
- Moderate
- severity level
- Class II
- classification
- March 31, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1295-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1295-2021) was formally reported on March 31, 2021, with the manufacturer initiating the action on February 18, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Ortho-Clinical Diagnostics, Inc. is listed as the recalling firm, operating out of Rochester, NY. Federal records list the affected scope as 7546 US and 15280 OUS kits.
The documented reason for this recall is: Potential total iron-binding capacity (TIBC) results. The VITROS TIBC performance shift will start with the newest Generation (GEN) of VITROS Fe Slides (GEN 26), the potential shift in TIBC patient values of GEN 26 and… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Brazil, Canada L3R 4G5, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portu…. 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
7546 US and 15280 OUS kits
Related Recalls
6
3 from same agency
Product description
VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems Product Code: 1204668 Impacted Products: A. VITROS Chemistry Products TIBC Kit Product No: 7541 (UDI 8750005178) All current and new lots B. VITROS Chemistry Products Fe Slides Product No: 1924547 90 Slides (UDI 10758750000289) Product No: 1515808 300 slides (UDI 10758750009244) Product No: 6802198 (Japan) 90 Slides (UDI 10758750002276) All current, new and previous lots
Reason for recall
Potential total iron-binding capacity (TIBC) results. The VITROS TIBC performance shift will start with the newest Generation (GEN) of VITROS Fe Slides (GEN 26), the potential shift in TIBC patient values of GEN 26 and above will be approximately 80 ug/dL lower across the measuring range than other available GENS of VITROS Fe Slides (GENs 22-25).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1295-2021 |
| Date reported | March 31, 2021 |
| Date initiated | February 18, 2021 |
| Recalling firm | Ortho-Clinical Diagnostics, Inc. |
| Firm location | Rochester, NY |
| Affected scope | 7546 US and 15280 OUS kits |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Brazil, Canada L3R 4G5, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapo… |
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-1295-2021) 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 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems Product Code: 1204668 Impacted Products: A. VITROS Chemistry Products TIBC Kit Product No: 7541 (UDI 8750005178) All current and new lots B. VITROS Chemistry Products Fe Slides Product No: 1924547 90 Slides (UDI 10758750000289) Product No: 1515808 300 slides (UDI 10758750009244) Product No: 6802198 (Japan) 90 Slides (UDI 10758750002276) All current, new and previous lots. Recalled by Ortho-Clinical Diagnostics, Inc.. Units affected: 7546 US and 15280 OUS kits.
Why was this product recalled? ▼
Potential total iron-binding capacity (TIBC) results. The VITROS TIBC performance shift will start with the newest Generation (GEN) of VITROS Fe Slides (GEN 26), the potential shift in TIBC patient values of GEN 26 and above will be approximately 80 ug/dL lower across the measuring range than other available GENS of VITROS Fe Slides (GENs 22-25).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 31, 2021. Severity: Moderate. Recall number: Z-1295-2021.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Brazil, Canada L3R 4G5, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1295-2021) 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 March 31, 2021. 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.