—#25733

Product

Vitros Immunodiagnostic Products *** UNIVERSAL WASH REAGENT *** for in vitro diagnostic use only. The product is sold in cartons containing 2 bottles (5 liters each). CAT 838 9793

510(k) numbers: K964310
Affected lot / code info: Lot 5003, Exp. 12 September 2003

Why it was recalled

Label printing irregularities on cartons and/or bottles.

Root cause (FDA determination)

Other

Action the firm took

Letters dated 1/10/03 sent U.S. Mail instructing customers to examine inventory and discard bottles or cartons with missing or illegible print.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Drive, Rochester, New York 14650-0881

Distribution

Distribution pattern: Product was shipped to medical facilities nationwide. There were 6 federal government consignees shipped product under government contract #V797-6565A. No product was shipped outside the U.S.

Timeline

Recall initiated: 2003-01-10
Posted by FDA: 2003-02-21
Terminated: 2003-06-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #25733. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.