Ortho-Clinical VITROS Calcium Slides Recalled for Biased Results
Ortho-Clinical Diagnostics is recalling VITROS Calcium Slides due to potential negatively biased results that may affect diagnosis.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may produce inaccurate diagnostic results, posing a risk of harm through misdiagnosis or treatment errors, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Ca Slides, GEN 29, because the company confirmed a potential for biased calcium results when used with specific VITROS Chemistry Systems. The investigation was prompted by an increase in complaints regarding negatively biased calcium results.
The affected product is used for in vitro diagnostic testing to quantitatively measure calcium concentration in serum, plasma, and urine. These measurements are utilized in the diagnosis and treatment of conditions such as parathyroid disease, bone disorders, chronic renal disease, and tetany. The recall covers 27,625 sales units in the United States and 4,757 sales units distributed to foreign countries including Australia, Brazil, Canada, and others.
Healthcare facilities and laboratories should stop using the affected lots immediately. Ortho-Clinical Diagnostics is the recalling firm responsible for the product.
The recalled product
- 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)…
- Manufacturer
- Ortho-Clinical Diagnostics
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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)
Distribution
Distributed nationwide across the United States.
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