FDA Device recall Z-1615-2013
VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990, Product Usage: For in vitro diagnostic use only
- FDA Device
- Class III
- terminated
- Published 2013-07-03
On 2013-07-03 the FDA classified a Class III recall of VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990, Product Usage: For in vitro diagnostic use only by Ortho Clinical Diagnostics, citing while performing interval testing Ortho Clinical Diagnostics (OCD) determined that an excess amount of surfactant was unintentionally added to VITROS Chemistry Products CRP Slides….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1615-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-05-09 |
| Published | 2013-07-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990, Product Usage: For 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.
Reason
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.
Identifiers
| code_info | GEN 3773, Coating 0766, Lot XXXX (exp. 11/01/2013); GEN 3784, Coating 0767, Lot XXXX (exp. 11/01/2013); and GEN 3785, C…GEN 3773, Coating 0766, Lot XXXX (exp. 11/01/2013); GEN 3784, Coating 0767, Lot XXXX (exp. 11/01/2013); and GEN 3785, Coating 0768, Lot XXXX (exp. 10/01/2013 and 11/01/2013). The term GEN and Coating refer to specific segments of the reagent lot number. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1615-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.