VITROS Valproic Acid (VALP) Reagent, REF/Catalog No. 6801710 --- Ortho- Clinical Diagnostics Rochester, NY USA -- Ortho-

FDA device recall Z-0984-2012 · posted 2012-02-08 · Terminated

Recall details

Recalling firm

Ortho-Clinical Diagnostics

Reason for recall

Results using VITROS Chemistry Products VALP Reagent were negatively biased compared to other manufacturers. OCD confirmed that patient results were also affected by this issue.

Action taken

All domestic end-user consignees were initially sent "Important Product Correction Notification" recall communications (dated 5/10/11) by Federal Express overnight mail on 5/10/11. The letters informed users of the issue, and advised them to discontinue using their VITROS VALP reagent until adjusted calibrator values are provided for GEN 14 of VITROS VALP Reagent. The adjusted calibrator values for VITROS VALP Reagent were sent to customers via Assay Data Disk (ADD) Data Release Version (DRV) 5632. Customers were to refer to the Technical Support Communication for details. Users were to confirm receipt of the notice by completing and returning the Fax Reply Form - Confirmation; confirm that all customers or distributors were informed of the issue and instructed to discontinue use of affected product; and lastly confirm that all customers or distributors were sent adjusted calibrator values.

Root cause

Manufacturing material removal

Status

Terminated

Product code

LEG

Quantity affected

Approximately 5800 units worldwide (domestic - 4549, foreign - 1287)

Distribution

Worldwide Distribution -- US, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.

Date initiated

2011-05-10

Date posted

2012-02-08

Date terminated

2016-02-12

Location

Rochester, NY

Related 510(k) clearances