Lower risk Medical device recall · FDA · Published April 17, 2023

Ortho-Clinical VITROS HbA1c Reagent Kit Recall: Risk of Misdiagnosis

Ortho-Clinical recalls VITROS HbA1c Reagent Kits due to potential for both positive and negative HbA1c results, which could lead to misdiagnosis of diabetes. Affected lots listed in the recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1628-2023Medical device Ortho-Clinical ›

Lower-risk recall

Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis

Take action

Contact the company

Recalling firmOrtho-Clinical Diagnostics, Inc.1001 Us Highway 202 · Raritan, NJ 08869-1424

✎ GovInfoNow plain-language explainer

Ortho-Clinical is recalling VITROS HbA1c Reagent Kits that could produce inaccurate blood sugar test results, leading to misdiagnosis of diabetes. This affects labs using specific lots of the reagent kits. Read more at govinfonow.com/recall/58549-ortho-clinical-vitros-hba1c-reagent-kit-recall-risk-of-misdiagnosis.

Source Summary by GovInfoNow · govinfonow.com/recall/58549-ortho-clinical-vitros-hba1c-reagent-kit-recall-risk-of-misdiagnosis · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1628-2023

Cite this page

“Ortho-Clinical VITROS HbA1c Reagent Kit Recall: Risk of Misdiagnosis.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58549-ortho-clinical-vitros-hba1c-reagent-kit-recall-risk-of-misdiagnosis. Based on FDA recall #Z-1628-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1628-2023%22&limit=1).

The FDA announced on April 17, 2023, that Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products HbA1c Reagent Kits due to the potential for unexpected positive or negative results. The agency said the hazard may result in misdiagnosis.

How to tell if you have it

Brand: Ortho-Clinical
Product: VITROS Chemistry Products HbA1c Reagent Kit- IVD
Product Code: 6842905
Lot Numbers/Expiry: 29-9396 2023-SEP-02; 29-9466 2023-SEP-02; 30-9647 2023-NOV-25; 30-9803 2023-NOV-25; 31-9648 2024-JAN-24; 32-9925 2024-APR-14; 33-1097 2024-JUL-18; 33-1105 2024-JUL-18; 33-1228 2024-JUL-18; 34-1345* 2024-OCT-17
Units affected: 23,751

The hazard

According to the FDA, the recalled kits have the potential for both unexpected positive and negative HbA1c results. The agency said this may result in misdiagnosis.

Context

GovInfoNow's records show Ortho-Clinical Diagnostics has 53 other recalls on record since July 10, 2017. Other recent recalls of similar products include Ortho-Clinical VITROS LAC Slides Recall (July 29, 2025), Ortho-Clinical VITROS Ca Slides Recall (July 9, 2025), and Ortho-Clinical VITROS OP Reagent Gen 15 May Cause Inaccurate Test Results (June 12, 2025). Other recent recalls of similar products include Siemens Atellica CH A1c_E Test Recall (June 8, 2026), Bioporto ProNephro AKI Reagent Kit Recall (May 18, 2026), and Siemens Atellica CH Urine Albumin Recall (July 6, 2026).

How to tell if you have this one

Check the lot numbers on the reagent kit packaging: 29-9396, 29-9466, 30-9647, 30-9803, 31-9648, 32-9925, 33-1097, 33-1105, 33-1228, or 34-1345. These lots were sold between September 2023 and October 2024.

Brand
Ortho-Clinical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Reagent Lot Number
Look for the lot numbers listed in the recall notice on the reagent kit packaging.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “US Nationwide- Worldwide Distribution. Foreign: Australia Belgium Brazil Bermuda HM12 Canada L3R 4G5 Chile China Colombia Denmark France France Germany India Italy Japan Mexico Norway Portugal Russia Singapore 609917 Spain Sweden The…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 44 days after the firm started it.

Apr 17, 2023Firm started the recall
May 24, 2023FDA classified it Class II
May 31, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using this reagent kit?

The recall does not require immediate stop use; labs should check the lot numbers and contact Ortho-Clinical if needed.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/58549-ortho-clinical-vitros-hba1c-reagent-kit-recall-risk-of-misdiagnosis">Ortho-Clinical VITROS HbA1c Reagent Kit Recall: Risk of Misdiagnosis (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1628-2023 (April 17, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1628-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.