Z-2273-2016Class II

VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No...

Name: Z-2273-2016 VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No...
Creator: Ortho-Clinical Diagnostics
Published: 2016-05-18
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2016-05-18 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or 20758750009111, IVD -- Sales Unit: 300... on 2016-05-18. FDA classified it as Class II and gives the reason as "Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be generated when using VITROS Ca Slides, GEN29, and the VITROS 250/350/950/5,1 FS, 4600 Chemistry System or the VITROS 5600...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2273-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-18
Posted: 2016-07-23
Terminated: 2018-06-08
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or 20758750009111, IVD -- Sales Unit: 300 slides/pack Product Usage: For in vitro diagnostic use only. VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disorders, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Product code: CJY Azo Dye, Calcium
Reason for recall: Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be generated when using VITROS Ca Slides, GEN29, and the VITROS 250/350/950/5,1 FS, 4600 Chemistry System or the VITROS 5600 Integrated System. An increase in negatively biased calcium results complaints prompted the investigation that identified this product issue.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Ortho Clinical Diagnostics sent an URGENT PRODUCT CORRECTION NOTIFICATION letter dated May 18, 2016 to affected customers. . The letter identified the affected product, problem and actions to be taken. The letter instructed to discontinue use of the affected lot(s) and discard all remaining inventory. Customers were asked to complete and return the Confirmation of Receipt form. For questions contact Customer Technical Services at 1-800-421-3311.
Quantity in commerce: US: 27,625 sales units; Foreign: 4757 sales units
Distribution: Worldwide Distribution - US Nationwide in the countries of Puerto Rico and Foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, Poland and Venezuela.
Product codes and lots: Lots #s: 0329-0528-8193 (exp. 05/01/2017), 0329-0528-8892 (exp. 06/01/2017), 0329-0528-8192 (exp. 05/01/2017), 0329-0528-8902 (exp. 06/01/2017), 0329-0528-8226 (exp. 05/01/2017), 0329-0528-8928 (exp. 07/01/2017), 0329-0528-8227 (exp. 05/01/2017), 0329-0528-9000 (exp. 07/01/2017), 0329-0528-8359 (exp. 05/01/2017), 0329-0528-8927 (exp. 07/01/2017), 0329-0528-8361 (exp. 05/01/2017), 0329-0528-8965 (exp. 07/01/2017), 0329-0528-8360 (exp. 05/01/2017), 0329-0528-8966 (exp. 07/01/2017), 0329-0528-8324 (exp. 05/01/2017), 0329-0528-9167 (exp. 07/01/2017), 0329-0528-8323 (exp. 05/01/2017), 0329-0528-9171 (exp. 07/01/2017), 0329-0528-8325 (exp. 05/01/2017), 0329-0528-9196 (exp. 07/01/2017), 0329-0528-6999 (exp. 03/01/2017), 0329-0528-9172 (exp. 07/01/2017), 0329-0528-7000 (exp. 03/01/2017), 0329-0528-9177 (exp. 07/01/2017), 0329-0528-6998 (exp. 03/01/2017), 0329-0528-9265 (exp. 07/01/2017), 0329-0528-8903 (exp. 06/01/2017), 0329-0528-9176 (exp. 07/01/2017), 0329-0528-8901 (exp. 06/01/2017), 0329-0528-9264 (exp. 07/01/2017), 0329-0528-8893 (exp. 06/01/2017), 0329-0528-9368 (exp. 07/01/2017), 0329-0528-8891 (exp. 06/01/2017), 0329-0528-9369 (exp. 07/01/2017).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2273-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2273-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-22

Product code CJY

K072440Class IIVitros Chemistry Products: Ca Slides (Model: 145 0261), Calibrators Kit 1 (Model: 188 2208)Ortho-Clinical Diagnostics, Inc. / cleared 2007-09-20

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)