Ortho-Clinical Diagnostics 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Ortho-Clinical Diagnostics
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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.
Ortho-Clinical Diagnostics is recalling Vitros Immunodiagnostic Products TROPONIN I Reagent Packs, (Lot 1110 and 1130 REF #194 9882 and Lo due to Random occurrence of false positive test results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Random occurrence of false positive test results.
Recommended Action
Per FDA guidance
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.
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