Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

CARTON LABEL: ''TDM Performance Verifier I''; 6 x 2 mL vials **** Catalog Number 896 2540 **** Made in USA by Ortho-Clinical Diagnostics , Inc., 100 Indigo Creek Drive, Rochester, NY 14626 ****

FDA Recall Z-0557-03 · Posted 2003-02-21

Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Date Initiated2002-12-18
Date Terminated2003-04-14
Product Quantity1,338 cartons

Reason for Recall

Cartons labeled 'TDM Performance Verifier I' may contain TDM Performance Verified II.

Firm Action

Letters dated 12/18/02 with instructions to inspect inventory and to discard affected product.

Root Cause

Other

Distribution Pattern

Nationwide distribution to medical facilities, distributors, and U.S. government consignees (39).

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013899VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORSOrtho-Clinical Diagnostics · 2002-01-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑