Z-0294-2014Class II

VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211 VITROS ALB Slides quantitatively...

Name: Z-0294-2014 VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211 VITROS ALB Slides quantitatively...
Creator: Ortho-Clinical Diagnostics
Published: 2013-06-12
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2013-06-12 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211 VITROS ALB Slides quantitatively measure (ALB) concentration in serum and plasma... on 2013-06-12. FDA classified it as Class II and gives the reason as "Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues". 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-0294-2014
Classification: Class II
Status: Terminated
Initiated: 2013-06-12
Posted: 2013-11-15
Terminated: 2017-04-11
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211 VITROS ALB Slides quantitatively measure (ALB) 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: CIX Bromcresol Green Dye-Binding, Albumin
Reason for recall: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Ortho Clinical Diagnostics sent an Important Product Correction Notification letter dated June 12, 2013, to all affected customers via FedEx regarding Slide Dispense issues with various VITROS Chemistry Product Slides. VITROS ALT, CL-, GGT, LDH, K+, Na+ and TP slides use a different ABP, they are not affected by this issue. OCD provided instructions that may allow their customers to reposition the ABP if a jam occurs. OCD will provide you with a credit for any cartridge where the ABP becomes misaligned within the cartridge body in such a way that you are unable to reposition the ABP successfully to resolve the slide dispense issue. In addition to the Confirmation of Receipt form, OCD also enclosed three (3) copies of a Request for Credit form for you to complete when you require credit for affected cartridges. Complete and return the Confirmation of Receipt by June 21, 2013. If you experience slide dispense condition codes more than once a week, call our Customer Technical Support at 1-800-421-3311. For questions regarding this recall call 585-453-4224.
Quantity in commerce: 16583 units (3073 domestically & 13510 internationally)
Distribution: Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.
Product codes and lots: Multiple lots affected, with expiry dates through 22-Mar-2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0294-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0292-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0293-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0294-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0295-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0296-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0297-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0298-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0299-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0300-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0301-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0302-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0303-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0304-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0305-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0306-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0307-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0308-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0309-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0310-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0311-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0312-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0313-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0314-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0315-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0316-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0317-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0318-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0319-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0320-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0321-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0322-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0323-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0324-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0325-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0326-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0327-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0328-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15

Product code CIX

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)