Z-1016-05

Vitros Chemistry CRBM Slides, REF 889 2382. There are 90 slides per box. For in vitro diagnostic use. Firm on...

Name: Z-1016-05 Vitros Chemistry CRBM Slides, REF 889 2382. There are 90 slides per box. For in vitro diagnostic use. Firm on...
Creator: Ortho-Clinical Diagnostics
Published: 2005-05-26
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2005-05-26 / Terminated

FDA source

Ortho-Clinical Diagnostics began a recall of Vitros Chemistry CRBM Slides, REF 889 2382. There are 90 slides per box. For in vitro diagnostic use. Firm on label: Ortho-Clinical Diagnostics, Inc... on 2005-05-26. The reason FDA records is "Falsely elevated Carbamazepine results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1016-05
Status: Terminated
Initiated: 2005-05-26
Posted: 2005-07-16
Terminated: 2006-06-12
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: Vitros Chemistry CRBM Slides, REF 889 2382. There are 90 slides per box. For in vitro diagnostic use. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626.
Product code: KLT Enzyme Immunoassay, Carbamazepine
Reason for recall: Falsely elevated Carbamazepine results.
FDA root cause: Other
Action: Letters dated 5/26/05 with instructions to discontinue use and discard slides. Customers also instructed to review previous results with Laboratory Medical Director to determine need for further consultation with health care provider.
Quantity in commerce: 5,846 boxes
Distribution: 423 U.S. consignees nationwide, and 22 OCD/J&J foreign affiliates (Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Peru, Ecuador, India, Japan, Mexico, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain)
Product codes and lots: Generations 18, 19, 20, 21, and 23

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)