Reported Jul 3, 2013 · Terminated
VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990, Product Usage: For in vitro…
Ortho-Clinical Diagnostics
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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 · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990
- Product UsageFor in vitro diagnostic use only. VITROS Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 Lot XXXX (exp. 11/01/2013); GEN 3784, Coating 0767 2 Lot XXXX (exp. 11/01/2013); and GEN 3785, Coating 0768 3 Lot XXXX (exp. 10/01/2013 and 11/01/2013). The term GEN and Coating refer to specific segments of the reagent 4 lot number. - Amount recalled
- Domestic: 4,257; Foreign: 923
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
While performing interval testing Ortho Clinical Diagnostics (OCD) determined that an excess amount of surfactant was unintentionally added to VITROS Chemistry Products CRP Slides during the manufacturing process.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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