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Terminated

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).

FDA Recall Z-2273-2016 · Posted None

Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeCJY
Date Initiated2016-05-18
Date Terminated2018-06-08
Product QuantityUS: 27,625 sales units; Foreign: 4757 sales units

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072440VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)Ortho-Clinical Diagnostics, Inc. · 2007-09-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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