Z-1470-2014Class II

VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro...

Name: Z-1470-2014 VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro...
Creator: Ortho-Clinical Diagnostics
Published: 2014-03-05
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2014-03-05 / Terminated

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products CRBM... on 2014-03-05. FDA classified it as Class II and gives the reason as "The firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS CRBM Slides, Lot 3920-0080-8403". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1470-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-05
Posted: 2014-04-17
Terminated: 2017-02-28
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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.
Product code: KLT Enzyme Immunoassay, Carbamazepine
Reason for recall: The firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS CRBM Slides, Lot 3920-0080-8403.
FDA root cause: Release of Material/Component prior to receiving test results
Action: 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.
Quantity in commerce: 20 units
Distribution: US Distribution to states of: IN, MD, and TN.
Product codes and lots: Lot 3920-0080-8403, expiry date 15-JUNE-2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1470-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1470-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-23	2014-04-17

Product code KLT

K980283Class IIVitros Chemistry Products Crbm SlidesJohnson & Johnson Clinical Diagnostics, Inc. / cleared 1998-02-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)