Recall Z-1876-2025
Ortho-Clinical Diagnostics, Inc. · initiated April 14, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
Codes / lots: Catalog number: 8097990; GTIN#: 10758750004355; Coating Number: 1291; Lot No. 3788-1291-0019, 3788-1291-0052, 3788-1291-0078, 3788-1291-0079, 3788-1291-0080, 3788-1291-9975.
Reason for recall
Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-1876-2025
- Initiated
- April 14, 2025
- Posted by FDA
- May 29, 2025
- Product code
- DCK – C-Reactive Protein, Antigen, Antiserum, And Control
- Quantity
- 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, Chile, Colombia, France, India, Italy, Mexico & Singapore.
- Recalling firm
- Ortho-Clinical Diagnostics, Inc., Rochester, NY