VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 9
FDA device recall Z-1876-2025 · posted 2025-05-29 · Open, Classified
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Reason for recall
- Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.
- Action taken
- An URGENT PRODUCT CORRECTION NOTIFICATION was mailed to consignees. The notification to distributors instructs consignees to forward the provided notification and Customer Confirmation Receipt to all customers who were shipped affected lots and to discontinue distributing affected lots. Affected lots in possession of distributors should be discarded. Distributors are asked to return a completed Distributor Confirmation Receipt form. The notification to customers instructs consignees to check their inventory and destroy any identified product subject to this recall. Consignees are instructed to post the provided notification near all VITROS devices and within device User Documentation until the issue has been resolved. A copy of the recall notification should be forwarded if a unit was distributed outside your facility. Consignees are to complete and return the provided Confirmation of Receipt form.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- DCK
- Quantity affected
- 3,587 units
- Distribution
- Worldwide - US Nationwide distribution in the states of AR, AZ, CO, FL, GA, ID, IL, IN, KS, MI, MN, MO, MS, MT, ND, NE, NH, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WI, WV & WY and the countries of Canada,
- Date initiated
- 2025-04-14
- Date posted
- 2025-05-29
- Location
- Rochester, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 (K152433) | Ortho Clinical Diagnostics | 2015-09-24 |
| EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP) (K953197) | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-07-31 |