Z-1224-03

Vitros Chemistry * GLU (glucose) Slides * 5 cartridges each containing 60 slides for a total of 300 tests...

Name: Z-1224-03 Vitros Chemistry *** GLU (glucose) Slides *** 5 cartridges each containing 60 slides for a total of 300 tests...
Creator: Ortho-Clinical Diagnostics
Published: 2003-07-28
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2003-07-28 / Terminated

FDA source

Ortho-Clinical Diagnostics began a recall of Vitros Chemistry *** GLU (glucose) Slides *** 5 cartridges each containing 60 slides for a total of 300 tests per box *** REF 170 7801 *** Ortho-Clinical... on 2003-07-28. The reason FDA records is "Results of glucose measurements on sodium fluoride/potassium oxalate specimens can be negatively biased when using Vitros GLU and GLU DT slides stored in the refrigerator. GLU slides are processed by high volume...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1224-03
Status: Terminated
Initiated: 2003-07-28
Posted: 2003-09-11
Terminated: 2003-11-24
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: Vitros Chemistry *** GLU (glucose) Slides *** 5 cartridges each containing 60 slides for a total of 300 tests per box *** REF 170 7801 *** Ortho-Clinical Diagnostics Inc., 100 Indigo Creek Drive, Rochester, NY 14626. [NOTE: product has an 18 month shelf life.]
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: Results of glucose measurements on sodium fluoride/potassium oxalate specimens can be negatively biased when using Vitros GLU and GLU DT slides stored in the refrigerator. GLU slides are processed by high volume chemistry systems typically used in hospital laboratories.
FDA root cause: Other
Action: GLU Slides: Letters dated between 7/28/03 and 8/11/03 provide revised storage instructions. Customers using NaF/KOx blood collection tubes and have VITROS GLU slides that have been refrigerated for more than four months will receive replacement product. Those customers are instructed to continue to use the slides only until replacement product arrives. GLU DT Slides: Letters dated between 7/28/03 and 8/11/03 with the same instructions as for GLU slides.
Quantity in commerce: 487,912 boxes
Distribution: Nationwide and worldwide distribution to distributors and end-users.
Product codes and lots: All lots with an expiration date of 1 December 2004 and earlier.

Product code CGA

K955286Class IIEktachem Clinical Chemistry Slide Glucose (Glu)Johnson & Johnson Clinical Diagnostics, Inc. / cleared 1996-05-17

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)