Z-0820-2007

VITROS Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194 9882. A Troponin Immunoassay...

Name: Z-0820-2007 VITROS Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194 9882. A Troponin Immunoassay...
Creator: Ortho-Clinical Diagnostics
Published: 2007-04-27
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2007-04-27 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194 9882. A Troponin Immunoassay Method, IVD. Ortho-Clinical Diagnostics, Amersham UK on 2007-04-27. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0820-2007
Status: Terminated
Initiated: 2007-04-27
Posted: 2007-05-26
Terminated: 2012-09-07
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194 9882. A Troponin Immunoassay Method, IVD. Ortho-Clinical Diagnostics, Amersham UK
Product code: MMI Immunoassay Method, Troponin Subunit
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: Lot 3151: 1,750 units, Lot 3170: 3,316 units
Distribution: Worldwide-including USA, Canada, and Bermuda
Product codes and lots: Lots 3151 and 3170

Product code MMI

K031031Class IIVitros Immunodiagnostic Products Troponin I Reagent Pack and CalibratorsOrtho-Clinical Diagnostics, Inc. / cleared 2003-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)