Z-0159-2027

MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM...

Name: Z-0159-2027 MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM...
Creator: Microgenics Corporation
Published: 2026-08-17
License: https://open.fda.gov/license/

Microgenics Corporation / initiated 2026-08-17 / Open, Classified

FDA source

Recall record

Recall number: Z-0159-2027
Status: Open, Classified
Initiated: 2026-08-17
Posted: 2026-10-15
Recalling firm: Microgenics Corporation
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
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
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 root 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 [email protected] 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 [email protected] 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: [email protected]
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.
Product codes and lots: REF/UDI-DI/Lot(Expiration): OPRO-101/00884883005327/OPRO29061A(2029-06-30); OPRO-SP/00884883005358/OPRO2906SA(2029-06-30)

Product code JJY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-10-21. View this recall on fda.gov (opens on fda.gov)