CLASS II ONGOING Device recall · Reported 5 Nov 2025 · FDA Enforcement Report

In Vitro Diagnostic external control recalled by Microgenics

Microgenics is recalling In Vitro Diagnostic external control, distributed nationwide in the US. The recall was initiated on 1 Oct 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesOCRD-UL: UDI/DI 00884883011946, Lot Number OCRD2704U, Exp 2027-04-30; OCRD-L: UDI/DI 00884883011953, Lot Number OCRD2704L, Exp 2027-04-30; OCRD-101: UDI/DI 00884883011960, Lot Number OCRD27041, Exp 2027-04-30; OCRD-202: UDI/DI 00884883011977, Lot Number OCRD27042, Exp 2027-04-30; OCRD-303: UDI/DI 00884883011984, Lot Number OCRD27043, Exp 2027-04-30; OCRD-SP: UDI/DI 00884883011991, Lot Number OCRD2704S, Exp 2027-04-30; OCRD-MP: UDI/DI 00884883012004, Lot Number OCRD2704M, Exp 2027-04-30.

Quantity recalled4462

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0415-2026
FDA event ID: 97745
Recalling firm: Microgenics, Fremont, CA
Classification: Class II
Status: Ongoing
Recall initiated: 1 Oct 2025
FDA classified: 30 Oct 2025
Reported: 5 Nov 2025
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Lead & Heavy Metals
Device type: Test Kits & Diagnostics

Timeline

1 Oct 2025	Recall initiated by company
30 Oct 2025	Classified by FDA	+29 days
5 Nov 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control

Where it was distributed

Worldwide - US Nationwide distribution in the states of AL, OK, NH, NY, WI, IL, LA, AR, TX, UT, GA, ID and the countries of MEX, CAN, KOR, MYS, DEU, GBR, BRA, JAP, HKG, NZL, AUS.

Nationwide Alabama Arkansas Georgia Idaho Illinois Louisiana New Hampshire New York Oklahoma Texas Utah Wisconsin

Questions about this recall

Is In Vitro Diagnostic external control recalled?

Yes. Microgenics recalled In Vitro Diagnostic external control on 1 Oct 2025. The recall is Class II and its status is Ongoing. Recall number Z-0415-2026.

Why was it recalled?

Which lots are affected?

OCRD-UL: UDI/DI 00884883011946, Lot Number OCRD2704U, Exp 2027-04-30; OCRD-L: UDI/DI 00884883011953, Lot Number OCRD2704L, Exp 2027-04-30; OCRD-101: UDI/DI 00884883011960, Lot Number OCRD27041, Exp 2027-04-30; OCRD-202: UDI/DI 00884883011977, Lot Number OCRD27042, Exp 2027-04-30; OCRD-303: UDI/DI 00884883011984, Lot Number OCRD27043, Exp 2027-04-30; OCRD-SP: UDI/DI 00884883011991, Lot Number OCRD2704S, Exp 2027-04-30; OCRD-MP: UDI/DI 00884883012004, Lot Number OCRD2704M, Exp 2027-04-30.

Where was it sold?

Worldwide - US Nationwide distribution in the states of AL, OK, NH, NY, WI, IL, LA, AR, TX, UT, GA, ID and the countries of MEX, CAN, KOR, MYS, DEU, GBR, BRA, JAP, HKG, NZL, AUS.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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