Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194 9882. A Troponin Immunoassay Method, IVD. Ortho-Clinical Diagnostics, Amersham UK Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VITROS Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194 9882. A Troponin Immunoassay Method, IVD. Ortho-Clinical Diagnostics, Amersham UK
Brand
Ortho-Clinical Diagnostics
Lot Codes / Batch Numbers
Lots 3151 and 3170
Products Sold
Lots 3151 and 3170
Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194 9882. A Troponin Immun due to Quality control and patient results can be lower than expected when the true Troponin I value is less than or equal to 0.2 ng/mL which may result in t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Quality control and patient results can be lower than expected when the true Troponin I value is less than or equal to 0.2 ng/mL which may result in the device failing to detect myocardial injury.
Recommended Action
Per FDA guidance
On 4/27/07, Ortho-Clinical Diagnostics in Rochester, NY, notified the end users of the recall of the product by phone, fax, and FedEx overnight letter. Clinical labs in possession of these lots have been contacted by OCD, and were instructed to (a) discontinue use of this product and (b) notify healthcare providers who ordered the test in recent weeks. Replacement product has been provided to clinical labs with the affected product lots. Clinical laboratories with questions may contact the company at 1-800-421-3311. On 4/27/07, OCD foreign affiliates were informed of this action by e-mail and instructed to inform their customers who received these reagent packs of this issue. Ortho-Clinical Diagnostics in Raritan, NJ, issued a nationwide press release on 5/04/07.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026