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Open, Classified

VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.

FDA Recall Z-1876-2025 · Posted 2025-05-29

Recall StatusOpen, Classified
Product CodeDCK
Date Initiated2025-04-14
Product Quantity3,587 units

Reason for Recall

Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.

Firm Action

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

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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