VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody t

FDA device recall Z-2671-2014 · posted 2014-09-19 · Terminated

Recall details

Recalling firm

ORTHO-CLINICAL DIAGNOSTICS

Reason for recall

VITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has been observed producing sporadic lower than expected VITROS Anti-HCV test results due to an approximate signal loss of up to 66.2% which can result in unexpected negative test results being obtained for reactive sample fluids (quality control and patient samples).

Action taken

All US consignees (users) who were shipped the affected lot VITROS HCV Reagent Pack were sent communications via FedEx and/or US Priority Mail (PO Boxes only) on 8/06/14, and advised of the issue and to immediately discontinue using all remaining inventory of VITROS Anti-HCV Reagent Packs Lot 9090. For additional information, please contact OCD's Customer Technical Service representatives at 1-800-421-3311.

Root cause

Packaging process control

Status

Terminated

Product code

MZO

Quantity affected

463 sales units

Distribution

NY, NJ, CT, MA, PA, VA, MD, FL and GA

Date initiated

2014-08-06

Date posted

2014-09-19

Date terminated

2017-04-14

Location

Bridgend, United Kingdom