CLASS II Device recall · Reported 3 Aug 2016 · FDA Enforcement Report
Vitros Chemistry Products Ca Slides, GEN recalled
Ortho-Clinical Diagnostics is recalling Vitros Chemistry Products Ca Slides, GEN 29, distributed nationwide in the US. The recall was initiated on 18 May 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2273-2016
- FDA event ID
- 74355
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 May 2016
- FDA classified
- 22 Jul 2016
- Reported
- 3 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 18 May 2016 | Recall initiated by company | |
| 22 Jul 2016 | Classified by FDA | +65 days |
| 3 Aug 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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).
Where it was distributed
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.
Questions about this recall
Why was it 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.
Which lots are affected?
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).
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ortho-Clinical Diagnostics
All 311| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Chemistry Products LAC Slides recalled by Ortho-Clinical Diagnostics | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Vitros Chemistry Products LAC Slides recalled | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Vitros Chemistry Products Ca Slides recalled | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Vitros Chemistry Products CHE Slides (Japan) recalled | Ortho-Clinical Diagnostics | Labeling Errors | Nationwide |
| Device | CLASS II | Vitros Chemistry Products CHE Slides recalled | Ortho-Clinical Diagnostics | Labeling Errors | Nationwide |
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