Class 2 Device Recall Thermo Fisher Scientific MAS Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control

• Date Initiated by Firm: August 17, 2026
• Date Posted: October 15, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0159-2027
• Recall Event ID: 99736
• Product Classification: Multi-analyte controls, all kinds (assayed) - Product Code JJY
• Product: MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM PRO Liquid Assayed Integrated Immunoassay Control, Sample Pack, REF: OPRO-SP
• Code Information: REF/UDI-DI/Lot(Expiration): OPRO-101/00884883005327/OPRO29061A(2029-06-30); OPRO-SP/00884883005358/OPRO2906SA(2029-06-30)
• FEI Number: 3010939897
• Recalling Firm/ Manufacturer: Microgenics Corporation; 46500 Kato Rd; Fremont CA 94538-7310
• Manufacturer Reason for Recall: Vial-to-vial variability in MAS Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone (PTH) recovery, which may lead to a delay in reporting patient PTH results.
• FDA Determined Cause: Process change control
• Action: On 8/17/2026, recall notices were emailed to customers asking them to do the following: 1) If the variability of the material (PTH Analyte) exceeds your laboratory's specification, dispose of the material. of the material in accordance with local, regional, and national regulations. 2) Contact TechService.mgc@thermofisher.com for any additional support. 3) Customers using the affected product can continue to use the product as long as it meets their laboratory's specification and continue monitoring performance of PTH analyte. 4) This recall notice needs to be passed to anyone within your organization or any organization where the potentially affected lot have been transferred. 5) Retain a copy of this letter for your laboratory records. 6) Complete and return the Recall Response Form via email to MGCFSCA@thermofisher.com In addition, distributors were asked to do the following: - Please notify your customers of this Recall Notice using this recall notice and request they return a response to your contact information. - Firm is providing a customer response form template as a word document. Please place this letter on to your own letterhead and collect responses from your customers on that customer response form. Please note, customers should provide their response directly to your contact information. If you have any additional questions regarding this Recall Notice, contact the firm at 1-800-232-3342 (USA and Canada only) or 510-979-5000 (International), option 2, then option 3 or by email: TechService.mgc@thermofisher.com
• Quantity in Commerce: 1366
• Distribution: Worldwide - US Nationwide distribution in the states of UT, MI, OK, NY, TX, CA, LA, SC, OH, MO, OR and the countries of KOR, BGD, THA, ZAF, DEU, VNM, BRA, NZL.
• Total Product Life Cycle: TPLC 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.