Z-1053-04

Vitros Immunodiagnostic Products TROPONIN I Reagent Packs, (Lot 1110 and 1130 REF #194 9882 and Lot 2510 and...

Name: Z-1053-04 Vitros Immunodiagnostic Products TROPONIN I Reagent Packs, (Lot 1110 and 1130 REF #194 9882 and Lot 2510 and...
Creator: Ortho-Clinical Diagnostics
Published: 2004-06-07
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2004-06-07 / Terminated

FDA source

Ortho-Clinical Diagnostics began a recall of Vitros Immunodiagnostic Products TROPONIN I Reagent Packs, (Lot 1110 and 1130 REF #194 9882 and Lot 2510 and 2530 REF #680 1857). Each reagent pack contains... on 2004-06-07. The reason FDA records is "Random occurrence of false positive test results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1053-04
Status: Terminated
Initiated: 2004-06-07
Posted: 2004-07-20
Terminated: 2005-04-18
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: Vitros Immunodiagnostic Products TROPONIN I Reagent Packs, (Lot 1110 and 1130 REF #194 9882 and Lot 2510 and 2530 REF #680 1857). Each reagent pack contains 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK.
Product code: MMI Immunoassay Method, Troponin Subunit
Reason for recall: Random occurrence of false positive test results.
FDA root cause: Other
Action: Domestic: Phone calls on 6/7-8/2004. Recall letters sent Federal Express on 6/7/2004. Foreign affiliates notified via e-mail on 6/7/2004. Customers instructed to discard inventory and notify health care providers. EXPANDED: Domestic: 7/1/2004 phone calls and faxes to consignees. FED EX letters mailed on 7/2/2004. Foreign affiliates notified via email on 6/30/2004.
Quantity in commerce: 5,185 reagent packs (6/7/04) & 1,507 reagent packs (6/30/04)
Distribution: 4,665 reagent packs shipped to domestic customers nationwide, including 8 federal government accounts (contract #V797P-6565A). 520 reagent packs shipped to 22 foreign affiliates who further distributed the product to: Asia Pacific, Canada, Caribbean, Chile, China, France, Germany, Italy, Mexico, Spain, UK and Northern Europe. EXPANDED: 440 reagent packs shipped to 13 domestic customers and 1,067 reagent packs shipped to 22 foreign affiliates.
Product codes and lots: Lot 1110 and Lot 2510 with exp. date of 8/11/04. EXPANDED 6/30/04 to include Lot 1130 and Lot 2530 with exp. date of 9/8/2004.

Product code MMI

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

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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)