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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Chemistry Product OP Reagent

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 Class 2 Device Recall VITROS Chemistry Product OP Reagentsee related information
Date Initiated by FirmJune 12, 2025
Date PostedJuly 02, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2073-2025
Recall Event ID 97034
510(K)NumberK062460 
Product Classification Enzyme immunoassay, opiates - Product Code DJG
ProductVITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine. One sales unit contains 6 Microtip packs of reagent. Each pack has 50 OP tests.
Code Information Model Number: 680 1997. UDI-DI: 10758750001835. Lot Numbers: 1527-15-2749 (exp. 17-Nov-2025), 1527-15-2771 (exp. 17-Dec-2025), 1527-15-2818 (exp. 11-Apr-2026), 1527-15-2871 (exp. 15-May-2026).
FEI Number 1000136573
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information ContactLaurie O'Riordan
954-6239546
Manufacturer Reason
for Recall		Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to run the OP-LO protocol leading to a potential delay in patient results.
FDA Determined
Cause 2		Under Investigation by firm
ActionQuidel Ortho notified consignees on about 06/12/2025 via FedEx letter. Distributors were instructed to discontinue distribution and discard inventory of any affected lots, send the provided customer letter and Confirmation of Receipt to any affected customers, and complete and return their Confirmation of Receipt. Customers were instructed that if their laboratory is unable to generate QC results within acceptable range using lots from GEN 15 of VITROS OP Reagent, discontinue using, render unusable, and discard your inventory of VITROS OP Reagent, GEN 15. Additionally, there were requested to complete and return the Confirmation of Receipt, maintain the notification with all records, and provide the notification if affected units were further distributed.
Quantity in Commerce2,017 units
DistributionWorldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DJG
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