Reported Aug 3, 2016 · Terminated
VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or…
Ortho-Clinical Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics · 513 Technology Blvd · Rochester, NY · 14626-3601
Is this the product you have?
- VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or 20758750009111
- IVD -- Sales Unit300
- slides/pack Product UsageFor 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)
- Lot codes and dates
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)
- Amount recalled
- US: 27,625 sales units; Foreign: 4757 sales units
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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