—#126327

Product

VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

FDA product code: KLT — Enzyme Immunoassay, Carbamazepine
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K980283
Affected lot / code info: Lot 3920-0080-8403, expiry date 15-JUNE-2014

Why it was recalled

The firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS CRBM Slides, Lot 3920-0080-8403.

Root cause (FDA determination)

Release of Material/Component prior to receiving test results

Action the firm took

The firm, Ortho Clinical Diagnostics, sent an "URGENT PRODUCT CORRECTION NOTIFICATION" letter (Ref. CL14-086; dated March 5, 2014) via FedEx Overnight Courier and/or US Postal Service Priority Mail (for PO Boxes only) to its US consignees (OCD Direct, Drop-Ship and US Federal Government). In addition, OCD proactively communicated with the 3 affected customers via phone to inform them of the potential issue and expedite product replacement. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue using and discard all remaining inventory of VITROS CRBM Slides, Lot 3920-0800-8403; review previously reported results using this lot; discuss any concerns regarding previously reported results with their Laboratory Medical Director or with the requesting physician; complete the attached Confirmation of Receipt form no later than March 14, 2014; and forward the information in this notification if you have distributed this product outside of your facility. If you have any additional questions, please contact Customer Technical Services at 1-800-421-3311.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Dr, Rochester, New York 14626-5101

Distribution

Distribution pattern: US Distribution to states of: IN, MD, and TN.

Timeline

Recall initiated: 2014-03-05
Posted by FDA: 2014-04-17
Terminated: 2017-02-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126327. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.